Careers

Working at Intuity Medical, Inc. could be the experience of a lifetime. Each of us is deeply passionate and committed to simplifying the lives of patients with diabetes and their caregivers. By joining our team, you’ll have the opportunity to improve the lives of millions of people.

If interested in an opportunity to join our team, simply email your resume to jobs@intuitymedical.com and reference the specific position of interest in the subject line.

Careers

Working at Intuity Medical, Inc. could be the experience of a lifetime. Each of us is deeply passionate and committed to simplifying the lives of patients with diabetes and their caregivers. By joining our team, you?ll have the opportunity to improve the lives of millions of people.

If interested in an opportunity to join our team, simply email your resume to jobs@intuitymedical.com and reference the specific position of interest in the subject line.

Current Opportunities

Customer Support

Customer Support Representative – this role is available through INTERVENT, a partner company to Intuity. All interested candidates must apply on Indeed directly to INTERVENT.

Basic Functions:

Receives and processes inbound and outbound phone calls/emails and chat messages for assigned clients and programs in accordance with corporate and department policies, procedures, quality standards, and applicable laws and regulations. As required, place calls to employers and end-users to assess and qualify new prospects and address customer inquiries, complaints and feedback while ensuring adherence to established policies and procedures. Establish a good working relationship with team members and department contacts in order to maintain, and continuously strive to improve the level of overall service being provided.

Major Job Accountabilities

Customer Care and Technical Job Functions:

    • Connect with customers in order to help resolve and find solutions to customer issues of a general and/or technical nature, while ensuring adherence to corporate and department policies and procedures
    • Exercise consistently exceptional communication skills (both listening and speaking) in an effort to optimize each contact with an existing or potential customer
    • Process inbound and outbound phone calls to collect information, investigate issues or diagnose and troubleshoot problems
    • Research and resolve customer issues, within the scope of responsibility
    • Make appropriate and track resolution referrals when customer issues fall outside the scope of responsibility
    • Obtain, enter and verify customer information in designated systems
    • Document customer notes with clear, concise explanations in a timely and accurate manner
    • Maintain established quality, calls per hour, and response time metrics, while supporting overall goals and objectives
    • Maintain excellent product knowledge

Lead Generation

    • As required, place calls to businesses and consumers in order to further qualify prospects or generate leads for assigned clients and programs, ensuring adherence to established policies and procedures
    • Optimize each contact by outlining opportunities and benefits of pursuing relationship with assigned client
    • Document leads based on client specifications in an accurate and timely manner
    • Maintain established calls per hour and response time metrics, while supporting Company goals and objectives

General Associate Job Responsibilities:

    • Demonstrate exceptional customer service skills in an effort to optimize each contact with the customer
    • Ensure that calls are processed in strict adherence to established policies, procedures, quality standards as well as applicable federal laws and regulations
    • Assist in resolving routine program quality issues by identifying issue(s) and researching in a timely manner
    • Maintain required documentation in an accurate and timely manner using established systems
    • Maintain strict confidentiality of information provided by customer or data accessed within assigned systems
    • Maintain an in-depth knowledge of assigned client’s products and service, as well as policies and procedures regarding customer calls
    • Establish and maintain a professional relationship with internal/external customers, team members and department contacts
    • Escalate to supervisor any situation outside the employee’s control that could adversely impact the services being provided
    • Exercise good judgment and common sense

Other Duties As May Be Assigned:

    • The job description documents the general nature and level of work but is not intended to be a comprehensive list of all activities, duties, and responsibilities required of job incumbents
    • Consequently, job incumbents may be asked to perform other duties as required
    • Also, note that reasonable accommodations may be made to enable individuals with disabilities to perform the functions outlined above.

Minimum Qualifications:

Minimum education requirements are:

    • Minimum of a bachelor’s Degree or HS diploma with equivalent work experience
    • Must meet the minimum age requirement for project and/or location of project
    • Additional education may be required based on individual projects and/or locations
    • Candidates shall meet the experience requirements as may be required for specific program assignments

Other

  • Based on Project and/or Location of Project the following may be required.
      • Ability to pass the standardized interview
      • Score acceptably on job-related testing assessments
      • Ability to work flexible schedules
      • Ability to clearly communicate using a clear, distinct voice
      • Based on program assignments may need to be fluent in English, Spanish, French, etc.
      • Present offers by reading scripted presentations verbatim or pending assigned team, following approved talking points/guidelines, paraphrasing, and customizing assigned presentations, in order to meet client requirements and bring customer issues to a satisfactory resolution
Finance

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Summary

Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution to the accounting department.

Key Responsibilities

    • Develop, enhance & maintain accounting policies and controls.
    • Monthly, quarterly and annual close process. Partner with FP&A on month-end close for accounting-related information as well as to understand business drivers that impact the financial results.
    • Review account reconciliations and perform variance analysis.
    • Drive annual audits including interactions with external auditors.
    • Design operational procedures and processes that meet audit standards and improve efficiency.
    • Assist in the development and compliance of internal controls and SOX requirements

Desired Skills And Background

    • 5+ years of experience with at least 2 years as an Accounting Manager with complete responsibility for the preparation of consolidated quarterly and annual financial statements.
    • Accounting or related degree.
    • Small to mid-sized public company experience
    • CPA or on track to complete their certification.
    • Experience with providing input into SEC filings is desirable.
    • Strong knowledge of US GAAP and preparation of footnotes. Preparation of statutory reports and experience in preparing 10Qs and 10Ks is desirable.
    • Must have been responsible for the management and development of an accounting staff of 2 or more, covering all GL, fixed assets, investments, AR, AP, and payroll functions.
    • Experience working in ERP systems. QAD desirable
    • Strong MS Office skills, especially Excel skills.
    • Proven track record in making improvements in all areas of accounting practices and policies.
    • Excellent analytical, interpersonal and communication skills.
    • Ability to conduct accounting research and write memos.
    • Must manage multiple priorities well and handle projects with short deadlines with extreme attention to detail.
    • Ability to work in a team-based environment.
    • Must be able to take full ownership of assignments and responsibilities.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  

Human Resources

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Position Summary:

The Human Resources Director reports to the Chief Financial Officer and is responsible for developing, implementing, and executing plans, programs, policies, and solutions in all areas of Human Resources including Staffing and Talent Acquisition, Compensation and Rewards, Employee Engagement, Benefits, Performance Management, and Compliance. This position is based in Intuity Medical’s Fremont headquarters office allowing for interaction with the 100+ staff who are onsite daily.  The availability to be onsite in the Fremont office is a key factor in the candidate selection process.  In addition, the Human Resources Director is a key participant in the company’s talent acquisition strategies and candidate selections to ensure our inclusive and start-up culture is enhanced.

Responsibilities:

  • Develop, lead, and deliver Human Resources and Talent Acquisition strategies for U.S. employee population of Intuity Medical.
  • Act as a liaison between the executive leadership team and staff to promote positive working relationships and provide strategic guidance to the organization.  Assist with creating the desired workplace culture to attract, retain, and motivate a high-performing, diverse workforce, enabling it to conduct its mission and achieve its objectives.
  • Guide, influence, evaluate and develop teams of business professionals to ensure the executive-team approved Human Resources strategy is implemented effectively.
  • Develop robust talent development plans in alignment with functional growth strategies of the department. Act as a catalyst in delivering Human Resources solutions to attract, develop, and retain talent to support the specific needs of the business groups and overall business objectives.
  • Participate in the interview/selection of talent in assigned client groups and perform compensation analysis to drive competitive offers. This position acts as the lead in managing all recruitment efforts for new employees, including candidate interviews.
  • Assist with full-cycle recruiting, including screening, evaluating, interviewing and candidate selection.
  • Evaluate current HR practices and help design, develop and implement progressive practices and programs such as talent acquisition, on-boarding, compensation, benefits, performance management, communication and employee and team development to meet the needs of a dynamic and growing team.
  • Coach, guide, and influence employees at all levels on HR programs, policies, best practices.

Experience and Requirements:

  • 8+ years progressive human resources experience in a generalist capacity.  Early-stage growth or start-up background is a plus as is manufacturing or medical device/life sciences industry experience.
  • Must have work experience/education that demonstrates full knowledge and application of effective HR methodologies with a strategic business mindset.
  • Remain current on appropriate CA and other U.S. states and Federal employment laws; provide direction, guidance, and management on legal requirements and government reporting regulations affecting internal policies and practices for HR functions, in collaboration with Legal Counsel, to ensure compliance with federal, state, and local regulatory agency guidelines and standards.
  • Broad knowledge and experience in all areas of Human Resources including Staffing and Retention, Compensation, Employee Relations, Benefits, HR Technology Systems, and Compliance.
  • Experience developing, implementing and communicating company benefits, performance management and compensation programs and HRIS tools.  The ability to participate in the selection of online HR and benefit administration tools is a plus.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills.
  • Excellent written and verbal communication skills and interpersonal relationship skills including influencing, consultative, and relationship management skills with ability to drive achievement of objectives at all levels of the company.
  • Creativity, business acumen, communication and writing skills along with sound judgement and good sense of humor are key.
  • Good computer skills including Microsoft Office (Word, Excel, PowerPoint), as well as experience with HRIS and ATS systems.
  • Bachelors degree.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Manufacturing

Company Overview

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet. Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.

Position Summary

This position requires a dynamic, energetic, self-driven, individual with an expertise in machinery and automation. This individual will support the scale up and manufacturing of a high-volume disposable medical device through day-to-day maintenance and production support for the automation equipment and will drive continuous improvement projects to increase equipment efficiencies. This individual will provide team leadership, directing the work of other maintenance personnel and sets a proper example of teamwork and cooperation when dealing with leads, supervisors and operators.

Position Responsibilities

    • Provide day-to-day maintenance and production support for the manufacturing equipment and staff. Development of machinery setup procedures and fixtures
    • Drive continuous improvement projects. Participates in process reviews recommends measures and drives projects to improve production methods, equipment performance and quality of product
    • Detect and solve routine production problems in all aspects of assigned processes.
    • Performs related and incidental work assignments as required. Maintain a presence on the manufacturing floor while splitting time on project work.
    • Communicates with supervisors leads, operators, maintenance, and engineers maintaining continuity among work teams by documenting and communicating actions, irregularities, and continuing needs
    • Observes and follows all safety procedures, Ensures safe operation of equipment and champions safety awareness. Keeps own and adjacent work areas clean.

Position Qualifications

    • Extensive experience in machine tools trade, machine building and automation
    • Strong fabrication, machining, and assembly skills
    • Experience installing, assembling, repairing, and maintaining industrial machinery / equipment.
    • Knowledge of machinery fundamentals, including pumps, motors, gearboxes, blowers, compressors etc.
    • Ability to understand schematic diagrams, blueprints, and other specifications. Reads and works to the indicated accuracy of specifications and tolerances as detailed on engineering drawings, machine assembly prints, blueprints, equipment manuals etc.
    • Possesses working knowledge of pneumatics, sensors, servo motors industrial automation devices
    • Detailed knowledge of general mechanical fundamentals such as fits and tolerances.
    • Strong mechanical experience, precision assembly, experience with difficult / custom intricate parts or have built complex machines
    • Working knowledge of pneumatics, sensors, servo motors industrial automation devices
    • Ability to work under minimal supervision, demonstrates knowledge and understanding of area specific equipment and processes.
    • Proficient in computer programs i.e., Microsoft Office
    • Experience working in regulated product or manufacturing environments (ISO, FDA, cGMP) is helpful

Education and Experience

    • Associates Degree or equivalent experience
    • 3+ years’ experience in manufacturing engineering or machine building and automation

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Summary of Responsibilities:

This position will primarily be responsible to coordinate, maintain and enhance the complaint handling program, including complaint trend analysis, returned product analysis and regulatory reporting (such as MDRs). The position is based in Intuity Medical’s Fremont headquarters office.

Responsibilities:

  • Develop, Coordinate and Maintain Complaint Handling Program and Adverse Event Reporting.
  • Receive, review and document complaint information timely and accurately.
  • Verify the complaint information is completed thoroughly by Customer Service, and determine if additional information is required to classify the complaint.
  • Establish a complaint report file for each individual complaint, organize and maintain all complaint records and monitor all complaint records to ensure timely closure.
  • Coordinate the process for complaint investigations and resolution, including returned goods evaluations, review of manufacturing records, decontamination and inspection of samples, evaluations of raw materials, manufacturing processes and DHR review, and testing as appropriate.
  • Maintain the complaint log timely and accurately to ensure inspection readiness at all times.
  • Establish complaint metrics and generate trend analysis for monthly updates.
  • Achieve technical and stylistic consistency between and among complaint documents to prevent contradicting information.
  • Continually provide guidance to all employees for handling complaint information.
  • Conduct returned product analysis investigations and DHR review. Document lab analysis results. Perform trending on complaint rates and provide feedback to management team.
  • Prepare initial and supplemental MDRs for regulatory reporting to the FDA in a timely manner. Ensure reporting of MDRs to FDA within 30 days.
  • Actively communicate with external suppliers, regulatory agencies, distributors, Intuity departments and sales representatives to ensure timely closure of complaint files.

Requirements:

  • Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements. Proficiency in MS Word, Excel, PowerPoint and Access.
  • Excellent organizational skills and ability to work on several projects at the same time; high level of attention to detail skills.
  • Work independently in a fast-paced manufacturing environment.
  • Capable of prioritizing responsibilities and completing tasks on schedule and contribute positively in a team environment.
  • Take initiative, motivation, good judgment, ability to manage multiple tasks with frequent interruptions, and high attention to detail and accuracy

Experience & Education:

  • 5+ years of experience working in complaint handling at a medical device organization.
  • Bachelors in Life Sciences or Engineering (preferred), or equivalent related experience and or training

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.


Summary of Primary Responsibilities
:

Individual reports to manufacturing and will also support R & D and Quality and be responsible for the following:

    • Execute maintenance and calibration activities within a GMP equipment maintenance and calibration system.
    • Provide any necessary technical support to ensure minimal downtime for all manufacturing and R & D equipment.
    • Use manual/semi-automated equipment to assemble the disposable cartridge products and re-usable meter and train staff as needed.
    • Support day to day manufacturing activities including line set-up, completing batch record documentation and meeting manufacturing goals.
    • Perform equipment engineering tasks as assigned and other related duties as assigned.
    • Comply with all safety policies, practices and procedures.
    • Proficiency with PCs, Microsoft Word and Excel.

Position Qualifications:

    • Ability to handle small, fragile parts under a microscope with dexterity.
    • Have knowledge of GMP.
    • Strong verbal and written communication skills.
    • Skilled in the use of automation to assist in the assembly processes.

Minimum Education:

    • High school diploma or general education degree or GED

Minimum Experience:

    • Minimum of 2 years of related experience, background in calibration is preferred but not mandatory.

Working Conditions:

The position may include work in a clean room, dry room or bio-hazardous environment and required wearing a lab coat, hair net, gloves. Must be able to lift 45 pounds.

Supervison: Supervised by Manufacturing Manager

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.


Position Summary

With some guidance from Senior Engineering Management, use sound engineering judgment to perform mechanical engineering analysis of proposed conceptual designs using classical engineering hand calculations as well as CAD software. Thermal, stress, vibration, data analysis and other mechanical engineering principals will be employed.

Position Responsibilities

    • Continuous manufacturing improvement utilizing tolerance analysis, statistical data analysis, understanding of machining and injection molding parts and processes
    • Participate in conceptual design of mechanisms and electro-mechanical systems using sketches and 3-D modeling software. DFM, DFX
    • Design fixtures and equipment for part inspection
    • Oversee and/or hands on execution of prototype fabrication and build.
    • Mechanical Engineering analysis of proposed conceptual designs using classical engineering hand calculations and software tools.
    • Perform design verification testing using engineering lab equipment such as push/pull tester, flow meter, sound meter, high speed video and metrology equipment.
    • Write assembly process documents, test/experiment procedures, test reports and status reports. NCMR/CAPA investigations and report generation.
    • Participate in design reviews by generating review material and presenting design review material
    • Write and execute technical protocols, IQ/OQ/PQ’s for manufacturing and injection molding processes
    • Perform root cause analysis on manufacturing defects and field return product
    • Participate in generating intellectual property to protect the company’s technological position and build value of the company
    • Generate project timelines and reliably execute to timelines using the available resources
    • Continuous improvement of testing and measurement methods to increase accuracy and throughput

 

Position Qualifications

    • Bachelors in Mechanical or Industrial Engineering
    • Experience with CAD Software (Solidworks preferred) is helpful
    • General Engineering: GD&T, Tolerance analysis, Injection Molding, Understanding of high-volume medical device manufacturing
    • Statistical Analysis: JMP or Minitab, DOE, Data analysis, Gauge R&R, Cpk, Ppk, SPC
    • 3+ years work experience

Position Summary:

Performs work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Ensures quality of product. Employees in this class are expected to quickly grasp new ideas and techniques, exercise independent judgment in the field and have a solid understanding of quality expectations. Essential duties and responsibilities include the following; other duties may be assigned: (1) Performs routine work in all production areas with limited supervision (2) Ensures quality of product through the use of standard operating procedures, templates, training, supervision and good judgment. (3) Provides input for enhancing efficiencies and modifying/creating SOPs to ensure accuracy/quality or improve productivity. Must have a firm understanding of quality expectations and standards and be able to make independent judgment based on those standards. Will also assist other team members within a broad range of work centers in a manner that best promotes the success of the Production Group.

Position Description and Responsibilities:

  • Maintain a safe and clean work space
  • Adhere to all company policies and procedures.
  • Follow established safety rules and regulations with a safety-first approach
  • Support day to day manufacturing activities including line set-up, completing electronic batch record documentation and meeting manufacturing goals
  • Feeding raw material or parts to semi-automated and automated machines
  • Carry out production, inspection, packaging and machine operation duties
  • Set up machinery and ensure all materials are readily available
  • Effectively monitor production equipment
  • Assist the shop technicians and materials clerk as necessary
  • Perform appropriate duties as assigned by management

Position Qualifications:

  • Working knowledge of diverse high-speed machinery in a manufacturing setting
  • Skilled in the use of automation to assist in assembly processes
  • Ability to control machines and processes using either control mechanisms or direct physical activity to operate machines or processes.
  • Ability to set up machines to start a production cycle
  • Ability to control and adjust machine settings, clear jams safely with a proper sense of urgency.
  • Strong verbal and written communication skills
  • Understanding of production procedures
  • Analytical skills
  • Attention to detail
  • Teamwork and communication skills
  • Physical stamina and strength
  • Able to lift a maximum of 50 pounds and stand for an eight-hour work shift

Minimum Education:

  • High school diploma

Minimum Experience:

  • 4+ years in an assembly environment, preferably in the medical device industry

Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Position Summary

This position works with Senior Engineering Management using sound engineering judgment to propose conceptual designs using classical engineering hand calculations as well as CAD software. Thermal, stress, vibration and other mechanical engineering principals will be employed.

Position Description and Responsibilities

  • Knowledge of tooling fabrication process for optimal product design. Fundamental knowledge of optical theory and application is desired. Tooling design for reliable PIM processes
  • Participate in design reviews by generating review material and presenting design review material. Write assembly process documents, test/experiment procedures, test and status reports
  • Must have strong, hands-on development capability. Experience with Machining (milling and lathe) and fixture design and assembly is helpful
  • Injection molding experience is helpful including Part design for PIM process
  • Must have a fundamental knowledge of statistical tools for: Tolerance analysis, Experiment design and Experiment result data analysis
  • Design, setup, and execute experiments and testing with minimal guidance
  • Must be able to proficiently use core elements of SolidWorks for part design, fixture design, and tooling review

Position Qualifications

  • Mechanical engineering and solid modeling
  • CAD and CAM software; MS Suite, Matlab desired
  • Previous experience in high volume part design is preferred
  • Bachelor’s in Mechanical, Industrial Engineering is preferred
  • 3+ years work experience

Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

 

Position Summary

The PLC Controls Engineer will support the scale up and manufacturing of a high-volume medical device. This position works closely with product development engineering, quality, materials planning and sourcing to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability. This position requires a dynamic, energetic, self-driven, technical engineer with a wide array of programming and control’s engineering skills. The PLC Controls Engineer will develop documentation (requirement specifications, drawings, qualification, and validation reports) to support the automation lines and equipment.

Position Responsibilities

  • Define automation needs, develop user requirement specifications and manage automation programs and project schedules.
  • Provides expertise in project planning and timeline development & management and will maintain schedules such that timelines are achieved.
  • Works with US based and international automation suppliers to deliver high volume manufacturing systems.
  • Responsible for preparation and execution of validation protocols and completion of validation reports.
  • Implement and manage process improvement and cost reduction programs. Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
  • Assist in product failure investigations and design changes required to improve product reliability and performance.

 Qualifications

  • Proficient in PLC Programming in Studio 5000 and RSLogix 5000
  • Experienced in FTView ME Software
  • Experience in managing an OT Network and various communication protocols
  • Proficiency in configuring and troubleshooting various sensors, drives and controllers
  • Experienced in working with Ignition.  Alternatively, proficiency in FTView SE or Wonderware
  • Thorough electrical knowledge, troubleshooting with a multimeter and ability to read electrical diagrams
  • Experience writing a functional description and RFP for automation systems. Ability to review design documents and set standards for machine builders and systems integrators
  • Experience programming vision systems (Cognex); experience with server management and virtualization and databases
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP) is helpful

Education and Experience

  • Bachelors in a related engineering discipline (mechanical, electrical, or chemical)
  • 3+ years work experience

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology,?Intuity’s POGO?Automatic??Blood Glucose Monitoring System aims to transform blood glucose testing.?More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

This position is part of a team of experienced assembly staff who assembles and inspects small assemblies according to written instructions. Staff members are crossed trained across multiple workstations according to general manufacturing principals, quality standards, as well as high standards of safety and workmanship.


Position Description and Responsibilities:

    • Day or Swing shifts are available Monday through Friday. Day has work hours of 5:30/6 AM to 1:30 PM. Swing has work hours of 1:30 PM to 10 PM. Training can occur during the Day time shift.
    • Performs assembly activities with the direction of the Production Supervisor
    • Handle and assemble small mechanical parts, often using a microscope to assemble.
    • Assist in inspection of parts, assist in keeping parts inventory
    • Assemble with automation
    • Perform duties by following written and verbal instructions.

Position Qualifications:

    • Ability to handle small, fragile parts under a microscope with dexterity.
    • Strong verbal and written communication skills
    • Helpful to have knowledge of general manufacturing principals.
    • Ability to package finished cartridges and relocate to packaging areas.

Desirable Skills:

    • Skilled in the use of automation to assist in the assembly processes
    • Skilled in the use of digital microscope systems and use of tweezers for assembly


Minimum Education & Experience:

    • High school diploma.
    • 1+ year in manufacturing, retail, life sciences industries.
    • Must have attention to detail, ability to handle small parts and willingness to work in a clean room environment.
    • helpful to have experience in assembly environment, preferably in the medical device or life sciences industries.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Position Summary:

Individual reports to the Director of Manufacturing and full technical support to production automated manufacturing equipment including; Preventive Maintenance, product change-overs and set-ups, troubleshooting, repairs, installation, process performance monitoring and ensures the product quality meets specifications. Collaborate with R&D and Operations engineers and Project Managers in a fast-paced setting.

Position Description and Responsibilities:

  • Debugs and replaces of pneumatic components and pick and place devices.
  • Assists with the installation of new systems and production equipment as needed.
  • Identifies and diagnoses failures, replaces defective components and performs basic troubleshooting using standard electronic equipment, detailed drawings, and machine manuals.
  • May provide backup assistance to Department Lead by assigning daily task to operators and/or assemblers as needed.
  • Provides operators and/or assemblers with technical training including the safe operation of equipment.
  • Assists operators in machine set-ups and adjustments as required.
  • Performs operator and/or assembly work as needed.
  • Reports any safety violation, machine equipment problems or misusage, and nonconformance work to Supervisor.
  • Inspects product using calipers, micrometer, scales, templates, or other measuring instruments to verify conformance.
  • Attends all required job-related training (internal and external)
  • Preventative maintenance, troubleshooting, and repair of molding machinery and auxiliary equipment.
  • Electrical, hydraulic, and pneumatic troubleshooting of production equipment per maintenance manuals and schematics.
  • PLC programming and troubleshooting.
  • Automation and robotic programming, setup, and troubleshooting.
  • Ability to work independently with equipment supplier support groups over the phone and on-site for required maintenance work.
  • Familiarity with machine shop equipment including mills, lathes, and other fabrication equipment.
  • Ability to conceptualize, design, and fabricate jigs, fixtures, and other production related materials with manual and CNC equipment.

Position Qualifications:

  • Analytical: Collects and researches data; uses intuition and experience to complement data; understands work flows and procedures.
  • Technical Skills: Able to clearly share expertise and transfer technical knowledge to others; Communicates technical knowledge and expertise with others. Strong mechanical abilities in order to set-up, troubleshoot, and operate assembly machinery.
  • Oral Communication: Speaks clearly and persuasively in positive or negative situations; listens intently to others and seeks clarification; Provides clear and pleasant responses to inquiries regardless of the situation; Presents complex concepts in a simple manner to achieve understanding.
  • Written Communication: Writes technical documents clearly and accurately; Transfers technical data into meaningful written documents that can be understood by all levels of the organization.
  • Team Work: Balances team and individual responsibilities; Exhibits objectivity and openness to others Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests.
  • Adaptability: Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Planning/Organizing: Prioritizes and plans work activities; Uses time efficiently.
  • Professionalism: Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Strong mechanical skills in order to troubleshoot and maintain proper operation of assembly machines.
  • Proficiency in Solidworks a plus

Minimum Education:

  • High school diploma or general education degree (GED); and a minimum of 2 years of recent experience and/or training in Assembly Automation.
  • Certification in Automation Technology, Electrical or Electronic Engineering or similar technical degree preferred

Minimum Experience: Minimum of 5 years of recent experience

Salary: $35.00/hour

Working Conditions:

While performing the duties of this Job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is required to sit; climb, balance, bend, stoop, kneel, crouch, and crawl. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include: close vision, distance vision, color vision, peripheral vision, and ability to adjust focus. Hearing level within normal/average range.

Position Summary:

This position requires a dynamic, energetic, self driven, engineer with a broad technical background. The Senior Manufacturing Process Engineer will support manufacturing operations for the production of complex electro-mechanical handheld instruments through the New Product Introduction process. This individual will be responsible for management of the contract manufacturer as well as the implementation and validation of manufacturing lines for Intuity products. Work closely with product development engineering, quality, materials planning and sourcing in order to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability. Develop manufacturing documentation (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers to build prototypes, pilot, and production instruments as appropriate. Troubleshoot and implement changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and the implementation/validation of equipment and process changes.


Position Description and Responsibilities:

  • Act as the primary technical point of contact; work with our Contract Manufacturer to transfer and scale the POGO meter manufacturing process.
  • Responsible for preparation and execution of validation protocols and completion of validation reports.
  • Provide expertise in project planning and timeline development & management and maintain project schedules and timelines
  • Work with local and international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning
  • Implement and manage process improvement and cost reduction programs. Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
  • Effectively utilize lean manufacturing tools for continuously improve the flow of material and information in the factory including factory layouts, visual management, 5S, JIT, Kanban
  • Assist in product failure investigations and design changes required to improve product reliability and performance.
  • As a member of the design team, evaluate and challenge mechanism designs for technical merit, reliability, and manufacturability.
  • Propose, review and approve design changes and change orders form a manufacturing and field perspective
  • Manage development transfer activities between R&D, Product development and operations to contract manufacturers
  • Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Position Qualifications:

  • Experience managing teams and leading large complex cross functional projects involving, electrical, electro-mechanical, optical and software elements.
  • Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
  • Experience with lean manufacturing, design for manufacturing, design for test and test implementation
  • Proficient in 3D mechanical modeling with SolidWorks
  • Excellent organizational, verbal and written communication skills as well as attention to details
  • Ability to coach and develop employees and develop effective cross functional relationships
  • Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education:

  • Minimum of a BS in a related science discipline

Minimum Experience:

  • 6+ years experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices
  • 3+ years in a senior engineering role either leading a team or acting as the primary technical interface to a CM

Working Conditions:

  • Travel required 20%

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

Work on a small team in a versatile role developing embedded firmware (C and C++) on a consumer medical device with multiple microcontrollers and computer software (visual C#) to control equipment and fixtures for manufacturing of the device. Contribute in developing requirement specifications, implementation and validation of software. Participate in code reviews and use case collaborations.

Position Description and Responsibilities:

    • Code in C++ and C# to control glucose meter and manufacturing test equipment
    • Provide documentation of code (specification, work instructions, DCO’s, etc.)
    • Write and execute test protocols to validate created software
    • Work within the source code control system in support of product Design History Record
    • Participate in design and code reviews by generating review material and presenting design review material
    • Contribute to the Intuity Medical Intellectual Property portfolio by generating patentable ideas or designs
    • Driven to succeed, and always looking to improve skills and expertise
    • Flexibility and a willingness to quickly change projects or project direction as required by the fast paced medical startup environment

Position Qualifications:

    • 8+ years of experiences in software design/development responsibilities
    • Proficiency in C++ ,? Visual C#
    • Embedded microcontroller device experience
    • Computer controlled hardware/software experience
    • Knowledge of standard coding concepts, practices, and procedures
    • Software development life cycle
    • Excellent written and verbal communication skills
    • Work well in a dynamic fast moving team

Minimum Education: BS or higher in Computer Science or Electrical Engineering

Working Conditions: Work with lab equipment and test fixtures

Desirable Skills: Knowledge of GMP and FDA design control documentation requirements a plus

Supervised by: Head of Manufacturing and Product Development


This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Product Development

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic? Blood Glucose Monitoring System is the world?s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

With minimal guidance from Senior Engineering Management, this position will augment the engineering staff by creating and releasing documentation packages for existing electro-mechanical parts and sub-assemblies. This role will also manage and maintain the PDM system (vault). Additionally, this position may also include the design/re-design of electromechanical components and sub-assemblies.

Responsibilities:

  • Create detailed drawings for existing components and sub-assemblies.
  • Produce 2-D drawings in support of design intent communication to Suppliers, Quality Assurance and Manufacturing using ANSI Y 14.5 GD&T dimensioning.
  • Create documentation packages for the production release of components and assemblies.
  • Create or revise Solidworks CAD models, drawings, BOM?s and other engineering documentation (DCO?s, NCR, etc.).
  • Develop and document fixtures/test equipment for used by Contract Manufacturer
  • Coordinate the inspection strategy for released components with responsible engineers and QC Department(s).
  • Maintain organized data base of design work using PDM software and company established guidelines in support of product Design History Record
  • Participate in design reviews by generating review material and presenting design review material.
  • Work with potential suppliers and manufacturing early and often during design development and part fabrication definition.
  • Contribute to the Intuity Medical Intellectual Property portfolio by generating patentable ideas or designs.

Position Qualifications:

  • 8+ years CAD software experience; 3+ years SolidWorks and Product Data Management (PDM Standard or Professional 2019+)
  • 5+ years in medical or consumer products industry within R&D or Manufacturing Engineering with proven track record of product development
  • Experience with Product Lifecycle Management Systems (PLM)
  • Knowledge of Tolerance Stack model building and analysis
  • Plastic injection molded and machined part design experience
  • Experience with printed circuit assemblies including rigid, flex and LCD displays and associated documentation package for fabrication and assembly

Desirable Skills:

  • Medical Device experience is strongly preferred
  • Experience with Arena PLM strongly preferred
  • Experience with Solidworks PDW Standard strongly preferred
  • Familiar with GMP and FDA Design Control documentation requirements preferred
  • Bilingual Spanish a plus

Education & Experience:

  • College degree is not required; some higher-level math (Algebra/Trig) is preferred
  • Minimum design experience 7+ years; Experience in related industry such as injection molding, machine shop and metal stamping operations can be substituted.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology,?Intuity’s POGO?Automatic??Blood Glucose Monitoring System aims to transform blood glucose testing.?More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

This individual will be a member of the product design and development team. With minimal guidance from Senior Engineering Management, use sound engineering judgment to analyze existing designs and lead their scale-up to high volume manufacturing. Analyze an interpret production data to determine opportunities for yield improvement; cost reduction; and improved quality via design for manufacturability. Will develop and optimize designs and implement high volume, manufacturable solutions for a highly integrated electromechanical system. Will ensure accurate transfer to manufacturing via: the completion of design verification/validation testing; creation and review of Manufacturing Process Instructions; and ownership of design changes via change control.

Position Description and Responsibilities:

  • Candidate should have experience transferring products from development to high volume manufacturing
  • Write assembly process documents, test/experiment procedures, test and status reports
  • Must have strong, hands on development capability and be willing to troubleshoot designs with a focus on understanding the critical elements that relate to overall product performance.
    • Fixture design and assembly
    • Component and mechanical/electro-mechanical assembly testing
  • Demonstrated ability to use statistical tools for:
    • Tolerance analysis
    • Experiment design and data analysis
    • JMP experience preferred.
  • Design, setup, and execute experiments and testing with minimal guidance
  • Participate in design reviews by generating review material and presenting design review material
  • Must have plastic injection molding (PIM) experience, including:
    • Part design for PIM process
    • Tooling design for reliable PIM processes
  • Fundamental knowledge of optical theory and application is desired
  • Must be able to proficiently use core elements of SolidWorks for part design, fixture design, and tooling review
  • Participate in generating intellectual property to protect the company?s technological position and build value of the company
  • Ability to lead and mentor junior engineers including acting as ?first-level? reviewer

Position Qualifications:

  • Mechanical engineering and solid modeling
  • CAD and CAM software
  • MS Suite
  • JMP (desired)
  • Previous experience in:
    • high volume part design (plastic product design experience required)
    • design verification testing
    • creation and review of manufacturing documentation (MPI, SOP)
    • electromechanical systems
    • statistical process control (desired)
  • Spanish Bilingual (plus)

Minimum Education:? BSME, MSME preferred

Minimum Experience:?? 7+ years applicable product design with BSME

Working Conditions: ?Some travel (<10%) possible

Supervision:? Supervised by:? Director of Product Design and Development

This job description in no way states or implies that these are the only duties to be performed by this employee.? He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Current Opportunities

Customer Support

<span style=”color: #27a0d9;”><b><i>Customer Support Representative</i></b><i> – <b>this role is available through <a href=”https://presspogo.com/blog/diabetes-gift-ideas-for-your-athlete/”>INTERVENT,</a> a partner company to Intuity</b>. All interested candidates must apply on Indeed directly to INTERVENT.</i></span>

<span style=”text-decoration: underline;”><strong>Basic Functions:</strong></span>

Receives and processes inbound and outbound phone calls/emails and chat messages for assigned clients and programs in accordance with corporate and department policies, procedures, quality standards, and applicable laws and regulations. As required, place calls to employers and end-users to assess and qualify new prospects and address customer inquiries, complaints and feedback while ensuring adherence to established policies and procedures. Establish a good working relationship with team members and department contacts in order to maintain, and continuously strive to improve the level of overall service being provided.

<span style=”text-decoration: underline;”><strong>Major Job Accountabilities</strong></span>

<strong>Customer Care and Technical Job Functions:</strong>
<ul>
<li>Connect with customers in order to help resolve and find solutions to customer issues of a general and/or technical nature, while ensuring adherence to corporate and department policies and procedures</li>
<li>Exercise consistently exceptional communication skills (both listening and speaking) in an effort to optimize each contact with an existing or potential customer</li>
<li>Process inbound and outbound phone calls to collect information, investigate issues or diagnose and troubleshoot problems</li>
<li>Research and resolve customer issues, within the scope of responsibility</li>
<li>Make appropriate and track resolution referrals when customer issues fall outside the scope of responsibility</li>
<li>Obtain, enter and verify customer information in designated systems</li>
<li>Document customer notes with clear, concise explanations in a timely and accurate manner</li>
<li>Maintain established quality, calls per hour, and response time metrics, while supporting overall goals and objectives</li>
<li>Maintain excellent product knowledge</li>
</ul>
<strong>Lead Generation</strong>
<ul>
<li>As required, place calls to businesses and consumers in order to further qualify prospects or generate leads for assigned clients and programs, ensuring adherence to established policies and procedures</li>
<li>Optimize each contact by outlining opportunities and benefits of pursuing relationship with assigned client</li>
<li>Document leads based on client specifications in an accurate and timely manner</li>
<li>Maintain established calls per hour and response time metrics, while supporting Company goals and objectives</li>
</ul>
<strong>General Associate Job Responsibilities:</strong>
<ul>
<li>Demonstrate exceptional customer service skills in an effort to optimize each contact with the customer</li>
<li>Ensure that calls are processed in strict adherence to established policies, procedures, quality standards as well as applicable federal laws and regulations</li>
<li>Assist in resolving routine program quality issues by identifying issue(s) and researching in a timely manner</li>
<li>Maintain required documentation in an accurate and timely manner using established systems</li>
<li>Maintain strict confidentiality of information provided by customer or data accessed within assigned systems</li>
<li>Maintain an in-depth knowledge of assigned client’s products and service, as well as policies and procedures regarding customer calls</li>
<li>Establish and maintain a professional relationship with internal/external customers, team members and department contacts</li>
<li>Escalate to supervisor any situation outside the employee’s control that could adversely impact the services being provided</li>
<li>Exercise good judgment and common sense</li>
</ul>
<strong>Other Duties As May Be Assigned:</strong>
<ul>
<li>The job description documents the general nature and level of work but is not intended to be a comprehensive list of all activities, duties, and responsibilities required of job incumbents</li>
<li>Consequently, job incumbents may be asked to perform other duties as required</li>
<li>Also, note that reasonable accommodations may be made to enable individuals with disabilities to perform the functions outlined above.</li>
</ul>
<strong>Minimum Qualifications:</strong>

Minimum education requirements are:
<ul>
<li>Minimum of a bachelor’s Degree or HS diploma with equivalent work experience</li>
<li>Must meet the minimum age requirement for project and/or location of project</li>
<li>Additional education may be required based on individual projects and/or locations</li>
<li>Candidates shall meet the experience requirements as may be required for specific program assignments</li>
</ul>
<p style=”padding-left: 40px;”>Other</p>

<ul>
<li>Based on Project and/or Location of Project the following may be required.
<ul>
<li>Ability to pass the standardized interview</li>
<li>Score acceptably on job-related testing assessments</li>
<li>Ability to work flexible schedules</li>
<li>Ability to clearly communicate using a clear, distinct voice</li>
<li>Based on program assignments may need to be fluent in English, Spanish, French, etc.</li>
<li>Present offers by reading scripted presentations verbatim or pending assigned team, following approved talking points/guidelines, paraphrasing, and customizing assigned presentations, in order to meet client requirements and bring customer issues to a satisfactory resolution</li>
</ul>
</li>
</ul>

Finance

<strong>Company Overview:</strong>

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic<sup>®</sup> Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

<strong><u>Summary</u></strong>

Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution to the accounting department.

<strong><u>Key Responsibilities</u></strong>
<ul>
<li>Develop, enhance & maintain accounting policies and controls.</li>
<li>Monthly, quarterly and annual close process. Partner with FP&A on month-end close for accounting-related information as well as to understand business drivers that impact the financial results.</li>
<li>Review account reconciliations and perform variance analysis.</li>
<li>Drive annual audits including interactions with external auditors.</li>
<li>Design operational procedures and processes that meet audit standards and improve efficiency.</li>
<li>Assist in the development and compliance of internal controls and SOX requirements</li>
</ul>
<strong><u>Desired Skills And Background</u></strong>
<ul>
<li>5+ years of experience with at least 2 years as an Accounting Manager with complete responsibility for the preparation of consolidated quarterly and annual financial statements.</li>
<li>Accounting or related degree.</li>
<li>Small to mid-sized public company experience</li>
<li>CPA or on track to complete their certification.</li>
<li>Experience with providing input into SEC filings is desirable.</li>
<li>Strong knowledge of US GAAP and preparation of footnotes. Preparation of statutory reports and experience in preparing 10Qs and 10Ks is desirable.</li>
<li>Must have been responsible for the management and development of an accounting staff of 2 or more, covering all GL, fixed assets, investments, AR, AP, and payroll functions.</li>
<li>Experience working in ERP systems. QAD desirable</li>
<li>Strong MS Office skills, especially Excel skills.</li>
<li>Proven track record in making improvements in all areas of accounting practices and policies.</li>
<li>Excellent analytical, interpersonal and communication skills.</li>
<li>Ability to conduct accounting research and write memos.</li>
<li>Must manage multiple priorities well and handle projects with short deadlines with extreme attention to detail.</li>
<li>Ability to work in a team-based environment.</li>
<li>Must be able to take full ownership of assignments and responsibilities.</li>
</ul>
<em>Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  </em>

Human Resources

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Position Summary:

The Human Resources Director reports to the Chief Financial Officer and is responsible for developing, implementing, and executing plans, programs, policies, and solutions in all areas of Human Resources including Staffing and Talent Acquisition, Compensation and Rewards, Employee Engagement, Benefits, Performance Management, and Compliance. This position is based in Intuity Medical’s Fremont headquarters office allowing for interaction with the 100+ staff who are onsite daily.  The availability to be onsite in the Fremont office is a key factor in the candidate selection process.  In addition, the Human Resources Director is a key participant in the company’s talent acquisition strategies and candidate selections to ensure our inclusive and start-up culture is enhanced.

Responsibilities:

  • Develop, lead, and deliver Human Resources and Talent Acquisition strategies for U.S. employee population of Intuity Medical.
  • Act as a liaison between the executive leadership team and staff to promote positive working relationships and provide strategic guidance to the organization.  Assist with creating the desired workplace culture to attract, retain, and motivate a high-performing, diverse workforce, enabling it to conduct its mission and achieve its objectives.
  • Guide, influence, evaluate and develop teams of business professionals to ensure the executive-team approved Human Resources strategy is implemented effectively.
  • Develop robust talent development plans in alignment with functional growth strategies of the department. Act as a catalyst in delivering Human Resources solutions to attract, develop, and retain talent to support the specific needs of the business groups and overall business objectives.
  • Participate in the interview/selection of talent in assigned client groups and perform compensation analysis to drive competitive offers. This position acts as the lead in managing all recruitment efforts for new employees, including candidate interviews.
  • Assist with full-cycle recruiting, including screening, evaluating, interviewing and candidate selection.
  • Evaluate current HR practices and help design, develop and implement progressive practices and programs such as talent acquisition, on-boarding, compensation, benefits, performance management, communication and employee and team development to meet the needs of a dynamic and growing team.
  • Coach, guide, and influence employees at all levels on HR programs, policies, best practices.

Experience and Requirements:

  • 8+ years progressive human resources experience in a generalist capacity.  Early-stage growth or start-up background is a plus as is manufacturing or medical device/life sciences industry experience.
  • Must have work experience/education that demonstrates full knowledge and application of effective HR methodologies with a strategic business mindset.
  • Remain current on appropriate CA and other U.S. states and Federal employment laws; provide direction, guidance, and management on legal requirements and government reporting regulations affecting internal policies and practices for HR functions, in collaboration with Legal Counsel, to ensure compliance with federal, state, and local regulatory agency guidelines and standards.
  • Broad knowledge and experience in all areas of Human Resources including Staffing and Retention, Compensation, Employee Relations, Benefits, HR Technology Systems, and Compliance.
  • Experience developing, implementing and communicating company benefits, performance management and compensation programs and HRIS tools.  The ability to participate in the selection of online HR and benefit administration tools is a plus.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills.
  • Excellent written and verbal communication skills and interpersonal relationship skills including influencing, consultative, and relationship management skills with ability to drive achievement of objectives at all levels of the company.
  • Creativity, business acumen, communication and writing skills along with sound judgement and good sense of humor are key.
  • Good computer skills including Microsoft Office (Word, Excel, PowerPoint), as well as experience with HRIS and ATS systems.
  • Bachelors degree.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Manufacturing

Company Overview

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet. Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.


Position Summary

This position requires a dynamic, energetic, self-driven, individual with an expertise in machinery and automation. This individual will support the scale up and manufacturing of a high-volume disposable medical device through day-to-day maintenance and production support for the automation equipment and will drive continuous improvement projects to increase equipment efficiencies. This individual will provide team leadership, directing the work of other maintenance personnel and sets a proper example of teamwork and cooperation when dealing with leads, supervisors and operators.

Position Responsibilities

  • Provide day-to-day maintenance and production support for the manufacturing equipment and staff. Development of machinery setup procedures and fixtures
  • Drive continuous improvement projects. Participates in process reviews recommends measures and drives projects to improve production methods, equipment performance and quality of product
  • Detect and solve routine production problems in all aspects of assigned processes.
  • Performs related and incidental work assignments as required. Maintain a presence on the manufacturing floor while splitting time on project work.
  • Communicates with supervisors leads, operators, maintenance, and engineers maintaining continuity among work teams by documenting and communicating actions, irregularities, and continuing needs
  • Observes and follows all safety procedures, Ensures safe operation of equipment and champions safety awareness. Keeps own and adjacent work areas clean

Position Qualifications

  • Extensive experience in machine tools trade, machine building and automation
  • Strong fabrication, machining, and assembly skills
  • Experience installing, assembling, repairing, and maintaining industrial machinery / equipment.
  • Knowledge of machinery fundamentals, including pumps, motors, gearboxes, blowers, compressors etc.
  • Ability to understand schematic diagrams, blueprints, and other specifications. Reads and works to the indicated accuracy of specifications and tolerances as detailed on engineering drawings, machine assembly prints, blueprints, equipment manuals etc.
  • Possesses working knowledge of pneumatics, sensors, servo motors industrial automation devices
  • Detailed knowledge of general mechanical fundamentals such as fits and tolerances.
  • Strong mechanical experience, precision assembly, experience with difficult / custom intricate parts or have built complex machines
  • Working knowledge of pneumatics, sensors, servo motors industrial automation devices
  • Ability to work under minimal supervision, demonstrates knowledge and understanding of area specific equipment and processes.
  • Proficient in computer programs i.e., Microsoft Office
  • Experience working in regulated product or manufacturing environments (ISO, FDA, cGMP) is helpful

Education and Experience

  • Associates Degree or equivalent experience
  • 3+ years’ experience in manufacturing engineering or machine building and automation

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Summary of Responsibilities:

This position will primarily be responsible to coordinate, maintain and enhance the complaint handling program, including complaint trend analysis, returned product analysis and regulatory reporting (such as MDRs). The position is based in Intuity Medical’s Fremont headquarters office.

Responsibilities:

  • Develop, Coordinate and Maintain Complaint Handling Program and Adverse Event Reporting.
  • Receive, review and document complaint information timely and accurately.
  • Verify the complaint information is completed thoroughly by Customer Service, and determine if additional information is required to classify the complaint.
  • Establish a complaint report file for each individual complaint, organize and maintain all complaint records and monitor all complaint records to ensure timely closure.
  • Coordinate the process for complaint investigations and resolution, including returned goods evaluations, review of manufacturing records, decontamination and inspection of samples, evaluations of raw materials, manufacturing processes and DHR review, and testing as appropriate.
  • Maintain the complaint log timely and accurately to ensure inspection readiness at all times.
  • Establish complaint metrics and generate trend analysis for monthly updates.
  • Achieve technical and stylistic consistency between and among complaint documents to prevent contradicting information.
  • Continually provide guidance to all employees for handling complaint information.
  • Conduct returned product analysis investigations and DHR review. Document lab analysis results. Perform trending on complaint rates and provide feedback to management team.
  • Prepare initial and supplemental MDRs for regulatory reporting to the FDA in a timely manner. Ensure reporting of MDRs to FDA within 30 days.
  • Actively communicate with external suppliers, regulatory agencies, distributors, Intuity departments and sales representatives to ensure timely closure of complaint files.

Requirements:

  • Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements. Proficiency in MS Word, Excel, PowerPoint and Access.
  • Excellent organizational skills and ability to work on several projects at the same time; high level of attention to detail skills.
  • Work independently in a fast-paced manufacturing environment.
  • Capable of prioritizing responsibilities and completing tasks on schedule and contribute positively in a team environment.
  • Take initiative, motivation, good judgment, ability to manage multiple tasks with frequent interruptions, and high attention to detail and accuracy

Experience & Education:

  • 5+ years of experience working in complaint handling at a medical device organization.
  • Bachelors in Life Sciences or Engineering (preferred), or equivalent related experience and or training

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

Individual reports to manufacturing and will also support R & D and Quality and be responsible for the following:

  • Execute maintenance and calibration activities within a GMP equipment maintenance and calibration system.
  • Provide any necessary technical support to ensure minimal downtime for all manufacturing and R & D equipment.
  • Use manual/semi-automated equipment to assemble the disposable cartridge products and re-usable meter and train staff as needed.
  • Support day to day manufacturing activities including line set-up, completing batch record documentation and meeting manufacturing goals.
  • Perform equipment engineering tasks as assigned and other related duties as assigned.
  • Comply with all safety policies, practices and procedures.
  • Proficiency with PCs, Microsoft Word and Excel.

Position Qualifications:

  • Ability to handle small, fragile parts under a microscope with dexterity.
  • Have knowledge of GMP.
  • Strong verbal and written communication skills.
  • Skilled in the use of automation to assist in the assembly processes.

Minimum Education:

  • High school diploma or general education degree or GED

Minimum Experience:

  • Minimum of 2 years of related experience, background in calibration is preferred but not mandatory.

Working Conditions:

The position may include work in a clean room, dry room or bio-hazardous environment and required wearing a lab coat, hair net, gloves. Must be able to lift 45 pounds.

Supervison: Supervised by Manufacturing Manager

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Position Summary

With some guidance from Senior Engineering Management, use sound engineering judgment to perform mechanical engineering analysis of proposed conceptual designs using classical engineering hand calculations as well as CAD software. Thermal, stress, vibration, data analysis and other mechanical engineering principals will be employed.

Position Responsibilities

  • Continuous manufacturing improvement utilizing tolerance analysis, statistical data analysis, understanding of machining and injection molding parts and processes
  • Participate in conceptual design of mechanisms and electro-mechanical systems using sketches and 3-D modeling software. DFM, DFX
  • Design fixtures and equipment for part inspection
  • Oversee and/or hands on execution of prototype fabrication and build.
  • Mechanical Engineering analysis of proposed conceptual designs using classical engineering hand calculations and software tools.
  • Perform design verification testing using engineering lab equipment such as push/pull tester, flow meter, sound meter, high speed video and metrology equipment.
  • Write assembly process documents, test/experiment procedures, test reports and status reports. NCMR/CAPA investigations and report generation.
  • Participate in design reviews by generating review material and presenting design review material
  • Write and execute technical protocols, IQ/OQ/PQ?s for manufacturing and injection molding processes
  • Perform root cause analysis on manufacturing defects and field return product
  • Participate in generating intellectual property to protect the company’s technological position and build value of the company
  • Generate project timelines and reliably execute to timelines using the available resources
  • Continuous improvement of testing and measurement methods to increase accuracy and throughput

 

Position Qualifications

  • Bachelors in Mechanical or Industrial Engineering
  • Experience with CAD Software (Solidworks preferred) is helpful
  • General Engineering: GD&T, Tolerance analysis, Injection Molding, Understanding of high-volume medical device manufacturing
  • Statistical Analysis: JMP or Minitab, DOE, Data analysis, Gauge R&R, Cpk, Ppk, SPC
  • 3+ years work experience

Position Summary:

Performs work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Ensures quality of product. Employees in this class are expected to quickly grasp new ideas and techniques, exercise independent judgment in the field and have a solid understanding of quality expectations. Essential duties and responsibilities include the following; other duties may be assigned: (1) Performs routine work in all production areas with limited supervision (2) Ensures quality of product through the use of standard operating procedures, templates, training, supervision and good judgment. (3) Provides input for enhancing efficiencies and modifying/creating SOPs to ensure accuracy/quality or improve productivity. Must have a firm understanding of quality expectations and standards and be able to make independent judgment based on those standards. Will also assist other team members within a broad range of work centers in a manner that best promotes the success of the Production Group.

Position Description and Responsibilities:

  • Maintain a safe and clean work space
  • Adhere to all company policies and procedures.
  • Follow established safety rules and regulations with a safety-first approach
  • Support day to day manufacturing activities including line set-up, completing electronic batch record documentation and meeting manufacturing goals
  • Feeding raw material or parts to semi-automated and automated machines
  • Carry out production, inspection, packaging and machine operation duties
  • Set up machinery and ensure all materials are readily available
  • Effectively monitor production equipment
  • Assist the shop technicians and materials clerk as necessary
  • Perform appropriate duties as assigned by management

Position Qualifications:

  • Working knowledge of diverse high-speed machinery in a manufacturing setting
  • Skilled in the use of automation to assist in assembly processes
  • Ability to control machines and processes using either control mechanisms or direct physical activity to operate machines or processes.
  • Ability to set up machines to start a production cycle
  • Ability to control and adjust machine settings, clear jams safely with a proper sense of urgency.
  • Strong verbal and written communication skills
  • Understanding of production procedures
  • Analytical skills
  • Attention to detail
  • Teamwork and communication skills
  • Physical stamina and strength
  • Able to lift a maximum of 50 pounds and stand for an eight-hour work shift

Minimum Education:

  • High school diploma

Minimum Experience:

  • 4+ years in an assembly environment, preferably in the medical device industry

Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Position Summary

This position works with Senior Engineering Management using sound engineering judgment to propose conceptual designs using classical engineering hand calculations as well as CAD software. Thermal, stress, vibration and other mechanical engineering principals will be employed.

Position Description and Responsibilities

  • Knowledge of tooling fabrication process for optimal product design. Fundamental knowledge of optical theory and application is desired. Tooling design for reliable PIM processes
  • Participate in design reviews by generating review material and presenting design review material. Write assembly process documents, test/experiment procedures, test and status reports
  • Must have strong, hands-on development capability. Experience with Machining (milling and lathe) and fixture design and assembly is helpful
  • Injection molding experience is helpful including Part design for PIM process
  • Must have a fundamental knowledge of statistical tools for: Tolerance analysis, Experiment design and Experiment result data analysis
  • Design, setup, and execute experiments and testing with minimal guidance
  • Must be able to proficiently use core elements of SolidWorks for part design, fixture design, and tooling review

Position Qualifications

  • Mechanical engineering and solid modeling
  • CAD and CAM software; MS Suite, Matlab desired
  • Previous experience in high volume part design is preferred
  • Bachelor’s in Mechanical, Industrial Engineering is preferred
  • 3+ years work experience
Company Overview

Intuity Medical, Inc. is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic® Blood Glucose Monitoring System is the world’s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

 

Position Summary

The PLC Controls Engineer will support the scale up and manufacturing of a high-volume medical device. This position works closely with product development engineering, quality, materials planning and sourcing to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability. This position requires a dynamic, energetic, self-driven, technical engineer with a wide array of programming and control’s engineering skills. The PLC Controls Engineer will develop documentation (requirement specifications, drawings, qualification, and validation reports) to support the automation lines and equipment.

 

Position Responsibilities

  • Define automation needs, develop user requirement specifications and manage automation programs and project schedules.
  • Provides expertise in project planning and timeline development & management and will maintain schedules such that timelines are achieved.
  • Works with US based and international automation suppliers to deliver high volume manufacturing systems.
  • Responsible for preparation and execution of validation protocols and completion of validation reports.
  • Implement and manage process improvement and cost reduction programs. Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
  • Assist in product failure investigations and design changes required to improve product reliability and performance.

 

 Qualifications

  • Proficient in PLC Programming in Studio 5000 and RSLogix 5000
  • Experienced in FTView ME Software
  • Experience in managing an OT Network and various communication protocols
  • Proficiency in configuring and troubleshooting various sensors, drives and controllers
  • Experienced in working with Ignition.  Alternatively, proficiency in FTView SE or Wonderware
  • Thorough electrical knowledge, troubleshooting with a multimeter and ability to read electrical diagrams
  • Experience writing a functional description and RFP for automation systems. Ability to review design documents and set standards for machine builders and systems integrators
  • Experience programming vision systems (Cognex); experience with server management and virtualization and databases
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP) is helpful

 

Education and Experience

  • Bachelors in a related engineering discipline (mechanical, electrical, or chemical)
  • 3+ years work experience

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

This position is part of a team of experienced assembly staff who assembles and inspects small assemblies according to written instructions. Staff members are crossed trained across multiple workstations according to general manufacturing principals, quality standards, as well as high standards of safety and workmanship.


Position Description and Responsibilities:

  • Day or Swing shifts are available Monday through Friday. Day has work hours of 5:30/6 AM to 1:30 PM. Swing has work hours of 1:30 PM to 10 PM. Training can occur during the Day time shift.
  • Performs assembly activities with the direction of the Production Supervisor
  • Handle and assemble small mechanical parts, often using a microscope to assemble.
  • Assist in inspection of parts, assist in keeping parts inventory
  • Assemble with automation
  • Perform duties by following written and verbal instructions.

Position Qualifications:

  • Ability to handle small, fragile parts under a microscope with dexterity.
  • Strong verbal and written communication skills
  • Helpful to have knowledge of general manufacturing principals.
  • Ability to package finished cartridges and relocate to packaging areas.

Desirable Skills:

  • Skilled in the use of automation to assist in the assembly processes
  • Skilled in the use of digital microscope systems and use of tweezers for assembly


Minimum Education & Experience:

  • High school diploma.
  • 1+ year in manufacturing, retail, life sciences industries.
  • Must have attention to detail, ability to handle small parts and willingness to work in a clean room environment.
  • helpful to have experience in assembly environment, preferably in the medical device or life sciences industries.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Position Summary:

Individual reports to the Director of Manufacturing and full technical support to production automated manufacturing equipment including; Preventive Maintenance, product change-overs and set-ups, troubleshooting, repairs, installation, process performance monitoring and ensures the product quality meets specifications. Collaborate with R&D and Operations engineers and Project Managers in a fast-paced setting.

Position Description and Responsibilities:

  • Debugs and replaces of pneumatic components and pick and place devices.
  • Assists with the installation of new systems and production equipment as needed.
  • Identifies and diagnoses failures, replaces defective components and performs basic troubleshooting using standard electronic equipment, detailed drawings, and machine manuals.
  • May provide backup assistance to Department Lead by assigning daily task to operators and/or assemblers as needed.
  • Provides operators and/or assemblers with technical training including the safe operation of equipment.
  • Assists operators in machine set-ups and adjustments as required.
  • Performs operator and/or assembly work as needed.
  • Reports any safety violation, machine equipment problems or misusage, and nonconformance work to Supervisor.
  • Inspects product using calipers, micrometer, scales, templates, or other measuring instruments to verify conformance.
  • Attends all required job-related training (internal and external)
  • Preventative maintenance, troubleshooting, and repair of molding machinery and auxiliary equipment.
  • Electrical, hydraulic, and pneumatic troubleshooting of production equipment per maintenance manuals and schematics.
  • PLC programming and troubleshooting.
  • Automation and robotic programming, setup, and troubleshooting.
  • Ability to work independently with equipment supplier support groups over the phone and on-site for required maintenance work.
  • Familiarity with machine shop equipment including mills, lathes, and other fabrication equipment.
  • Ability to conceptualize, design, and fabricate jigs, fixtures, and other production related materials with manual and CNC equipment.

Position Qualifications:

  • Analytical: Collects and researches data; uses intuition and experience to complement data; understands work flows and procedures.
  • Technical Skills: Able to clearly share expertise and transfer technical knowledge to others; Communicates technical knowledge and expertise with others. Strong mechanical abilities in order to set-up, troubleshoot, and operate assembly machinery.
  • Oral Communication: Speaks clearly and persuasively in positive or negative situations; listens intently to others and seeks clarification; Provides clear and pleasant responses to inquiries regardless of the situation; Presents complex concepts in a simple manner to achieve understanding.
  • Written Communication: Writes technical documents clearly and accurately; Transfers technical data into meaningful written documents that can be understood by all levels of the organization.
  • Team Work: Balances team and individual responsibilities; Exhibits objectivity and openness to others Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests.
  • Adaptability: Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Planning/Organizing: Prioritizes and plans work activities; Uses time efficiently.
  • Professionalism: Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Strong mechanical skills in order to troubleshoot and maintain proper operation of assembly machines.
  • Proficiency in Solidworks a plus

Minimum Education:

  • High school diploma or general education degree (GED); and a minimum of 2 years of recent experience and/or training in Assembly Automation.
  • Certification in Automation Technology, Electrical or Electronic Engineering or similar technical degree preferred

Minimum Experience:

  • Minimum of 5 years of recent experience

Salary:

$35.00/hour

Working Conditions:

While performing the duties of this Job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is required to sit; climb, balance, bend, stoop, kneel, crouch, and crawl. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include: close vision, distance vision, color vision, peripheral vision, and ability to adjust focus. Hearing level within normal/average range.

Position Summary:

This position requires a dynamic, energetic, self driven, engineer with a broad technical background. The Senior Manufacturing Process Engineer will support manufacturing operations for the production of complex electro-mechanical handheld instruments through the New Product Introduction process. This individual will be responsible for management of the contract manufacturer as well as the implementation and validation of manufacturing lines for Intuity products. Work closely with product development engineering, quality, materials planning and sourcing in order to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability. Develop manufacturing documentation (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers to build prototypes, pilot, and production instruments as appropriate. Troubleshoot and implement changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and the implementation/validation of equipment and process changes.

Position Description and Responsibilities:

  • Act as the primary technical point of contact; work with our Contract Manufacturer to transfer and scale the POGO meter manufacturing process.
  • Responsible for preparation and execution of validation protocols and completion of validation reports.
  • Provide expertise in project planning and timeline development & management and maintain project schedules and timelines
  • Work with local and international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning
  • Implement and manage process improvement and cost reduction programs. Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
  • Effectively utilize lean manufacturing tools for continuously improve the flow of material and information in the factory including factory layouts, visual management, 5S, JIT, Kanban
  • Assist in product failure investigations and design changes required to improve product reliability and performance.
  • As a member of the design team, evaluate and challenge mechanism designs for technical merit, reliability, and manufacturability.
  • Propose, review and approve design changes and change orders form a manufacturing and field perspective
  • Manage development transfer activities between R&D, Product development and operations to contract manufacturers
  • Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Position Qualifications:

  • Experience managing teams and leading large complex cross functional projects involving, electrical, electro-mechanical, optical and software elements.
  • Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
  • Experience with lean manufacturing, design for manufacturing, design for test and test implementation
  • Proficient in 3D mechanical modeling with SolidWorks
  • Excellent organizational, verbal and written communication skills as well as attention to details
  • Ability to coach and develop employees and develop effective cross functional relationships
  • Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education:

  • Minimum of a BS in a related science discipline

Minimum Experience:

  • 6+ years experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices
  • 3+ years in a senior engineering role either leading a team or acting as the primary technical interface to a CM

Working Conditions:

  • Travel required 20%

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology, Intuity’s POGO Automatic® Blood Glucose Monitoring System aims to transform blood glucose testing. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

Work on a small team in a versatile role developing embedded firmware (C and C++) on a consumer medical device with multiple microcontrollers and computer software (visual C#) to control equipment and fixtures for manufacturing of the device. Contribute in developing requirement specifications, implementation and validation of software. Participate in code reviews and use case collaborations.

Position Description and Responsibilities:

  • Code in C++ and C# to control glucose meter and manufacturing test equipment
  • Provide documentation of code (specification, work instructions, DCO’s, etc.)
  • Write and execute test protocols to validate created software
  • Work within the source code control system in support of product Design History Record
  • Participate in design and code reviews by generating review material and presenting design review material
  • Contribute to the Intuity Medical Intellectual Property portfolio by generating patentable ideas or designs
  • Driven to succeed, and always looking to improve skills and expertise
  • Flexibility and a willingness to quickly change projects or project direction as required by the fast paced medical startup environment

Position Qualifications:

  • 8+ years of experiences in software design/development responsibilities
  • Proficiency in C++ , Visual C#
  • Embedded microcontroller device experience
  • Computer controlled hardware/software experience
  • Knowledge of standard coding concepts, practices, and procedures
  • Software development life cycle
  • Excellent written and verbal communication skills
  • Work well in a dynamic fast moving team

Minimum Education: BS or higher in Computer Science or Electrical Engineering

Working Conditions: Work with lab equipment and test fixtures

Desirable Skills: Knowledge of GMP and FDA design control documentation requirements a plus

Supervised by: Head of Manufacturing and Product Development


This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Product Development

Company Overview:

Intuity Medical is a fast-paced, growing medical device company headquartered in Silicon Valley that has developed a greatly simplified glucose monitoring system for people with diabetes. Our POGO Automatic? Blood Glucose Monitoring System is the world?s first FDA-cleared automatic, one-step blood glucose meter that combines lancing, blood collection, and analysis into a single 10-test cartridge. POGO Automatic provides a convenient and discreet solution for millions of patients who need to regularly test their blood glucose. More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

With minimal guidance from Senior Engineering Management, this position will augment the engineering staff by creating and releasing documentation packages for existing electro-mechanical parts and sub-assemblies. This role will also manage and maintain the PDM system (vault). Additionally, this position may also include the design/re-design of electromechanical components and sub-assemblies.

Responsibilities:

  • Create detailed drawings for existing components and sub-assemblies.
  • Produce 2-D drawings in support of design intent communication to Suppliers, Quality Assurance and Manufacturing using ANSI Y 14.5 GD&T dimensioning.
  • Create documentation packages for the production release of components and assemblies.
  • Create or revise Solidworks CAD models, drawings, BOM?s and other engineering documentation (DCO?s, NCR, etc.).
  • Develop and document fixtures/test equipment for used by Contract Manufacturer
  • Coordinate the inspection strategy for released components with responsible engineers and QC Department(s).
  • Maintain organized data base of design work using PDM software and company established guidelines in support of product Design History Record
  • Participate in design reviews by generating review material and presenting design review material.
  • Work with potential suppliers and manufacturing early and often during design development and part fabrication definition.
  • Contribute to the Intuity Medical Intellectual Property portfolio by generating patentable ideas or designs.

Position Qualifications:

  • 8+ years CAD software experience; 3+ years SolidWorks and Product Data Management (PDM Standard or Professional 2019+)
  • 5+ years in medical or consumer products industry within R&D or Manufacturing Engineering with proven track record of product development
  • Experience with Product Lifecycle Management Systems (PLM)
  • Knowledge of Tolerance Stack model building and analysis
  • Plastic injection molded and machined part design experience
  • Experience with printed circuit assemblies including rigid, flex and LCD displays and associated documentation package for fabrication and assembly

Desirable Skills:

  • Medical Device experience is strongly preferred
  • Experience with Arena PLM strongly preferred
  • Experience with Solidworks PDW Standard strongly preferred
  • Familiar with GMP and FDA Design Control documentation requirements preferred
  • Bilingual Spanish a plus

Education & Experience:

  • College degree is not required; some higher-level math (Algebra/Trig) is preferred
  • Minimum design experience 7+ years; Experience in related industry such as injection molding, machine shop and metal stamping operations can be substituted.

Intuity Medical values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

Company Overview:

Intuity Medical, Inc. is a privately held, fast paced, growing medical device company located in Fremont, CA. Our company was founded with the mission of simplifying diabetes management for persons living with diabetes. We have developed the first FDA-cleared automatic blood glucose monitoring system with a 10-test cartridge designed to make testing easy, convenient and discreet.

Through innovative and proprietary technology,?Intuity’s POGO?Automatic??Blood Glucose Monitoring System aims to transform blood glucose testing.?More information regarding our technology can be found at www.presspogo.com.

Summary of Primary Responsibilities:

This individual will be a member of the product design and development team. With minimal guidance from Senior Engineering Management, use sound engineering judgment to analyze existing designs and lead their scale-up to high volume manufacturing. Analyze an interpret production data to determine opportunities for yield improvement; cost reduction; and improved quality via design for manufacturability. Will develop and optimize designs and implement high volume, manufacturable solutions for a highly integrated electromechanical system. Will ensure accurate transfer to manufacturing via: the completion of design verification/validation testing; creation and review of Manufacturing Process Instructions; and ownership of design changes via change control.

Position Description and Responsibilities:

  • Candidate should have experience transferring products from development to high volume manufacturing
  • Write assembly process documents, test/experiment procedures, test and status reports
  • Must have strong, hands on development capability and be willing to troubleshoot designs with a focus on understanding the critical elements that relate to overall product performance.
    • Fixture design and assembly
    • Component and mechanical/electro-mechanical assembly testing
  • Demonstrated ability to use statistical tools for:
    • Tolerance analysis
    • Experiment design and data analysis
    • JMP experience preferred.
  • Design, setup, and execute experiments and testing with minimal guidance
  • Participate in design reviews by generating review material and presenting design review material
  • Must have plastic injection molding (PIM) experience, including:
    • Part design for PIM process
    • Tooling design for reliable PIM processes
  • Fundamental knowledge of optical theory and application is desired
  • Must be able to proficiently use core elements of SolidWorks for part design, fixture design, and tooling review
  • Participate in generating intellectual property to protect the company?s technological position and build value of the company
  • Ability to lead and mentor junior engineers including acting as ?first-level? reviewer

Position Qualifications:

  • Mechanical engineering and solid modeling
  • CAD and CAM software
  • MS Suite
  • JMP (desired)
  • Previous experience in:
    • high volume part design (plastic product design experience required)
    • design verification testing
    • creation and review of manufacturing documentation (MPI, SOP)
    • electromechanical systems
    • statistical process control (desired)
  • Spanish Bilingual (plus)

Minimum Education:? BSME, MSME preferred

Minimum Experience:?? 7+ years applicable product design with BSME

Working Conditions: ?Some travel (<10%) possible

Supervision:? Supervised by:? Director of Product Design and Development

This job description in no way states or implies that these are the only duties to be performed by this employee.? He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Our customer support team is available
Monday to Friday 9:00AM to 9:00PM Eastern Time (ET)
at 1-855-IMI-POGO (464-7646) or email us at
support@presspogohelp.com

Background graphic image of POGO Automatic logo design

Our customer support team is available Monday to Friday 9:00AM to 9:00PM Eastern Time (ET) at 1-855-IMI-POGO (464-7646) or email us at support@presspogohelp.com

Background graphic image of POGO Automatic logo design

Our customer support team is available Monday to Friday 9:00AM to 9:00PM Eastern Time (ET) at 1-855-IMI-POGO (464-7646) or email us at support@presspogohelp.com

Background graphic image of POGO Automatic logo design