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

Call Center Manager – this role is available through INTERVENT, a partner company to Intuity Medical, Inc. All interested candidates must apply on Indeed directly to INTERVENT, apply here.

Summary of Duties:
Responsible for managing, supervising, and scheduling a team of customer support representatives that have been designated to provide support to all customers and potential customers on behalf of a dynamic, fast growing healthcare company that produces and sells an innovative blood glucose monitoring system.

Summary of Major Job Responsibilities:
See the Indeed job post for additional information.

Program Profitability

• By using key performance indicators, the manager will routinely analyze business results to ensure that performance gaps are identified and develop and plan adjustments to close any gaps

Employee and Personal Leadership Development

• Coach, develop and mentor subordinates, while continuing to develop personal management skills necessary to lead staff and handle unique management challenges. Promote employee development by establishing performance measures that encourage employees to excel. Continually assess personal management skills.

Staff Resources

• Identify all resources required for program team to successfully perform their job duties, requesting additional support when needed. Acts as a liaison between different stakeholders

Motivation and Recognition

• Responsible for meeting and exceeding client expectations and driving profitable business growth by delivering client results, recommending and implementing program improvements and following client policies.

Deliver Client Results

• Responsible for delivering client statistics and reports indicating program and productivity results in agreed upon timeframes, may include KPIs’ and productivity metrics.

Recommends and Implements Program Improvements

• Responsible for proactively identifying ways to drive program effectiveness and efficiency, reviewing recommendations with management staff and client, implementing mutually agreed upon improvements.

Follows Policies and Specifications

• Responsible for following written documentation and implementing mutually agreed upon client procedures, work instructions, scripts and monitoring staff adherence, advising management staff of necessary modifications.

Communication

• Communicates with client liaison, management staff and other identified contacts. Recaps, in writing, and documents in appropriate system, all decisions made in conference calls and distributes to client, management staff and other applicable parties on a timely basis. Actively communicates program performance and initiatives to program team.

Education: Minimum of a bachelor’s degree (preferably Master degree) in business administration from accredited college or university required, with major course work in business administration, operations, marketing, or a related field.

Experience: Minimum 5 years managing an inbound call center team, operations, technical support, business administration, working in a healthcare environment/regulated industry is a plus.

How to Apply:
Interested candidates must apply on Indeed directly to INTERVENT, apply here.

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 Description and 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
  • Completes required maintenance and calibration records
  • Observes and follows all safety procedures, Ensures safe operation of equipment and champions safety awareness.  Keeps own and adjacent work areas clean
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

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.
  • Experience and proficiency with metrology instruments: calipers, micrometers, dial indicators, gage blocks
  • 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.  Learns understands and can implement all policies, practices, and procedures
  • Strong oral and written communication skills.  Strong interpersonal and leadership skills
    • Ability to maintain a positive and professional working relationship with peers, management and support resources, with a constant commitment to teamwork
  • Ability to coach and develop employees and develop effective cross functional relationships
  • Proficient in computer programs i.e., Microsoft Office
  • Experience working in a production facility
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education: Associates Degree or equivalent experience

Minimum Experience: 7+ years’ experience in manufacturing engineering or machine building and automation

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 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 some guidance from Senior Engineering Management, use sound engineering judgment to perform M.E. 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, assembly and test.
  • 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:

  • B.S. or M.S. Mechanical Engineering CAD Software (Solidworks preferred)
  • 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

Minimum Education: BS Mechanical Engineering

Minimum Experience: 3+ years

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 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:

  • Sound working knowledge of lean manufacturing with demonstrated team participation and/or leadership and related continuous improvement successes.
  • Experience in leadership, problem solving, conflict resolution, and organization.
  • Provide direction and guidance to Technicians, Operators, and other support staff.
  • Responsible for execution of the manufacturing schedule. Prepare and Communicate manufacturing KPI’s. Coaches and develops team members.
  • Participate in Lean initiatives. Assist in updating SOPs, as necessary.
  • Provide support for the Quality System during corporate audits, actively participate in department activities and confirm compliance with controlled procedures as required.
  • Report on all resource issues such as personnel, materials and equipment.
  • Creates and cultivates a culture centered around Safety, Quality, and Teamwork to ensure adherence to all safety and quality applicable regulations.
  • Participates in the recruiting process and coaches their team throughout the recruiting and onboarding process.
  • Proactively participates in and provides support to established change management processes to drive continuous improvement.
  • Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures.

Position Description and Responsibilities:

  • Act as a liaison between clean room staff and management.
  • Manage multiple projects with multiple departments in a timely and efficient manner.
  • Strong verbal and written communication skills.
  • Able to operate manual and computer-controlled manufacturing equipment.
  • Strong attention to detail, including ability to read and revise documents.
  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment.
  • A team player with a positive attitude. Strong interpersonal skills.

Position Qualifications: Experience in a clean room automated manufacturing environment

Education: Associate or Bachelors n a technical or business-related field preferred; or relevant technical background and work experience.

Minimum Experience:

  • Minimum of 5 Years’ experience in a manufacturing leadership role.
  • Automated medical device clean room manufacturing environment preferred.

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.

Position Summary:

Intuity Medical is seeking a Material Handler 2 position with responsibilities to include the coordination of warehousing and distribution functions, staging material for production work orders, receiving incoming goods and ensuring inventory accuracy.  Ensure compliance with Good Manufacturing Practices (GMP’s) associated with the Handling, Storage, and Distribution functions.

Duties and Responsibilities:

  • Performs the physical or administrative tasks involved in the shipping, receiving, storing and distribution of materials, parts, supplies and equipment
  • Unpacks and checks goods received against purchase orders or invoices, maintains records of receiving goods, rejected/non-conforming materials and cycle counts
  • Prepares and maintains records of merchandise shipped
  • Posts weights and shipping charges and prepares goods for final shipment
  • Examines stock and distributes materials in inventory via Production Order pick lists and/or KanBan replenishment location/s in support of manufacturing requirements
  • Reviews MRP reports to assist in daily distribution requirements
  • Other duties as assigned

Experience:

  • 2+ years’ experience in shipping, receiving, inventory control and regulatory guidelines (GMP, ISO, FDA)
  • Proficient in MS Office, QAD and/or equivalent ERP systems
  • Forklift experienced and/or certified
  • Proficient with PLM systems (Arena, Agile, etc.)

Education: High school diploma or equivalent

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:

With minimal guidance from Senior Engineering Management, use 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 as appropriate.

Position Description and Responsibilities:

  • Must have strong, hands on development capability
  • Machining (milling and lathe)
  • Fixture design and assembly
  • Testing
  • Must have injection molding experience, including:
  • Part design for PIM process
  • Tooling design for reliable PIM processes
  • Knowledge of tooling fabrication process for optimal product design
  • Fundamental knowledge of optical theory and application is desired
  • Must have a fundamental knowledge of statistical tools for:
  • Tolerance analysis
  • Experiment design
  • 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
  • Write assembly process documents, test/experiment procedures, test and status reports
  • Participate in design reviews by generating review material and presenting design review material
  • Participate in generating intellectual property to protect the company’s technological position and build value of the company

Position Qualifications:

  • Mechanical engineering and solid modeling
  • CAD and CAM software
  • MS Suite
  • Matlab desired
  • Previous experience in high volume part design (plastic product design experience required)

Minimum Education:

  • BSME

Minimum Experience:

  • 2+ years applicable product design with BSME

Working Conditions:

Some travel (<10%) possible

Position Summary:

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 support the scale up and manufacturing of a high volume disposable medical device. This individual will be responsible for defining system requirements, automation and electrical standards, and managing the automation infrastructure and systems. Will develop project schedules, budgets and provide direct oversight and management of automation suppliers, machine OEM’s and service contractors, as well as driving the implementation and validation of manufacturing lines for Intuity products. This individual will 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. This individual will develop documentation (requirement specifications, drawings, qualification and validation reports) to support the automation lines and equipment. The individual will perform troubleshooting and implement process changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, documentation, and the implementation/validation of equipment and process changes

Position Description and 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.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Position 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 manage contractors
  • Ability to review design documents and set standards for machine builders and systems integrators
  • Service oriented mentality
  • Experience programming vision systems (Cognex)
  • Experience with databases
  • Experience with server management and virtualization
  • Excellent organizational, verbal and written communication skills as well as attention to details
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education:

  • Minimum of a BS in a related engineering discipline (mechanical, electrical, or chemical)

Minimum Experience:

  • 15 years experience in manufacturing and automation engineering

Working Conditions:

  • Travel required 20-30%

Supervised by:

  • Director of 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.

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:

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.

Product Development

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.

Quality Engineering

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.

Shift:
Swing shift

Summary of Primary Responsibilities:
Perform wide range of inspection of incoming purchased parts, raw material, assemblies, and subassemblies. Perform inspection of in-process, final assembly, and returned goods. Collaborate with Quality, Product Development and Manufacturing to address nonconformities.

Position Description and Responsibilities:

  • Perform and document detailed incoming inspections
  • Perform and document detailed first article inspections
  • Initiate Nonconforming Materials Reports and perform actions needed to determine product disposition, as required
  • Maintain and file inspection documentation (both hard and soft copies)
  • Maintain a clean and organized lab
  • Maintain an Inspection Log
  • Maintain IQC Lab Equipment/Fixtures:
    • Perform Preventive Maintenance when required (e.g., cleaning the equipment/fixtures)
    • Perform Calibration when required
    • Ensure equipment requiring outside calibration is turned into the calibration coordinator before the due date
    • Ensure equipment is properly labeled and identified
  • Maintain QC inspection sample retains
  • Provide input for inspection methods and improvements related to the job
  • Perform in-process, final assembly inspection, and returned goods inspection, as required
  • Perform other duties as assigned


Position Qualifications:

  • Ability to interpret engineering drawings (GD&T), receipt/shop travelers, purchase orders, procedures, bills of materials and supplier documentation
  • Ability to utilize various inspection tools (i.e., optical comparator or other vision inspection systems, micrometers, various gages, etc.)
  • Ability to manage workload to effectively and efficiently complete tasks within time constraints
  • Possess a strong work ethic, a positive attitude, good organization skills, and attention to detail
  • Act as a team member to identify and resolves issues
  • Familiar with ISO13485 and FDA QSR regulations
  • Knowledge of c= 0 and ANSI/ASQ Z1.4 Sampling Plans as it relates to verification activities
  • Competent computer and software application skills
  • Excellent verbal and written communication skills


Desirable Skills:

  • Experience with CMM PC-DMIS and OGP SmartScope Flash Software (MeasureMind) and/or Keyence Image Dimension Measuring System

Certificates Licenses and Registrations:

  • ASQ CQI (Certified Quality Inspector) preferred

Minimum Education/Experience:

  • AS or AA degree preferred
  • Minimum three (3) years of QA inspection experience in the medical device industry


Supervision:
  Supervised by Sr. Director, QA/RA

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

Call Center Manager – this role is available through INTERVENT, a partner company to Intuity Medical, Inc. All interested candidates must apply on Indeed directly to INTERVENT, apply here.

Summary of Duties:
Responsible for managing, supervising, and scheduling a team of customer support representatives that have been designated to provide support to all customers and potential customers on behalf of a dynamic, fast growing healthcare company that produces and sells an innovative blood glucose monitoring system.

Summary of Major Job Responsibilities:
See the Indeed job post for additional information.

Program Profitability

• By using key performance indicators, the manager will routinely analyze business results to ensure that performance gaps are identified and develop and plan adjustments to close any gaps

Employee and Personal Leadership Development

• Coach, develop and mentor subordinates, while continuing to develop personal management skills necessary to lead staff and handle unique management challenges. Promote employee development by establishing performance measures that encourage employees to excel. Continually assess personal management skills.

Staff Resources

• Identify all resources required for program team to successfully perform their job duties, requesting additional support when needed. Acts as a liaison between different stakeholders

Motivation and Recognition

• Responsible for meeting and exceeding client expectations and driving profitable business growth by delivering client results, recommending and implementing program improvements and following client policies.

Deliver Client Results

• Responsible for delivering client statistics and reports indicating program and productivity results in agreed upon timeframes, may include KPIs’ and productivity metrics.

Recommends and Implements Program Improvements

• Responsible for proactively identifying ways to drive program effectiveness and efficiency, reviewing recommendations with management staff and client, implementing mutually agreed upon improvements.

Follows Policies and Specifications

• Responsible for following written documentation and implementing mutually agreed upon client procedures, work instructions, scripts and monitoring staff adherence, advising management staff of necessary modifications.

Communication

• Communicates with client liaison, management staff and other identified contacts. Recaps, in writing, and documents in appropriate system, all decisions made in conference calls and distributes to client, management staff and other applicable parties on a timely basis. Actively communicates program performance and initiatives to program team.

Education: Minimum of a bachelor’s degree (preferably Master degree) in business administration from accredited college or university required, with major course work in business administration, operations, marketing, or a related field.

Experience: Minimum 5 years managing an inbound call center team, operations, technical support, business administration, working in a healthcare environment/regulated industry is a plus.

How to Apply:
Interested candidates must apply on Indeed directly to INTERVENT, apply here.

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 Description and 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
  • Completes required maintenance and calibration records
  • Observes and follows all safety procedures, Ensures safe operation of equipment and champions safety awareness.  Keeps own and adjacent work areas clean
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

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.
  • Experience and proficiency with metrology instruments: calipers, micrometers, dial indicators, gage blocks
  • 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.  Learns understands and can implement all policies, practices, and procedures
  • Strong oral and written communication skills.  Strong interpersonal and leadership skills
    • Ability to maintain a positive and professional working relationship with peers, management and support resources, with a constant commitment to teamwork
  • Ability to coach and develop employees and develop effective cross functional relationships
  • Proficient in computer programs i.e., Microsoft Office
  • Experience working in a production facility
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education: Associates Degree or equivalent experience

Minimum Experience: 7+ years’ experience in manufacturing engineering or machine building and automation

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 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 some guidance from Senior Engineering Management, use sound engineering judgment to perform M.E. 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, assembly and test.
  • 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:

  • B.S. or M.S. Mechanical Engineering CAD Software (Solidworks preferred)
  • 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

Minimum Education: BS Mechanical Engineering

Minimum Experience: 3+ years

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 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:

  • Sound working knowledge of lean manufacturing with demonstrated team participation and/or leadership and related continuous improvement successes.
  • Experience in leadership, problem solving, conflict resolution, and organization.
  • Provide direction and guidance to Technicians, Operators, and other support staff.
  • Responsible for execution of the manufacturing schedule. Prepare and Communicate manufacturing KPI’s. Coaches and develops team members.
  • Participate in Lean initiatives. Assist in updating SOPs, as necessary.
  • Provide support for the Quality System during corporate audits, actively participate in department activities and confirm compliance with controlled procedures as required.
  • Report on all resource issues such as personnel, materials and equipment.
  • Creates and cultivates a culture centered around Safety, Quality, and Teamwork to ensure adherence to all safety and quality applicable regulations.
  • Participates in the recruiting process and coaches their team throughout the recruiting and onboarding process.
  • Proactively participates in and provides support to established change management processes to drive continuous improvement.
  • Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures.

Position Description and Responsibilities:

  • Act as a liaison between clean room staff and management.
  • Manage multiple projects with multiple departments in a timely and efficient manner.
  • Strong verbal and written communication skills.
  • Able to operate manual and computer-controlled manufacturing equipment.
  • Strong attention to detail, including ability to read and revise documents.
  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment.
  • A team player with a positive attitude. Strong interpersonal skills.

Position Qualifications: Experience in a clean room automated manufacturing environment

Education: Associate or Bachelors n a technical or business-related field preferred; or relevant technical background and work experience.

Minimum Experience:

  • Minimum of 5 Years’ experience in a manufacturing leadership role.
  • Automated medical device clean room manufacturing environment preferred.

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.

Position Summary:

Intuity Medical is seeking a Material Handler 2 position with responsibilities to include the coordination of warehousing and distribution functions, staging material for production work orders, receiving incoming goods and ensuring inventory accuracy.  Ensure compliance with Good Manufacturing Practices (GMP’s) associated with the Handling, Storage, and Distribution functions.

Duties and Responsibilities:

  • Performs the physical or administrative tasks involved in the shipping, receiving, storing and distribution of materials, parts, supplies and equipment
  • Unpacks and checks goods received against purchase orders or invoices, maintains records of receiving goods, rejected/non-conforming materials and cycle counts
  • Prepares and maintains records of merchandise shipped
  • Posts weights and shipping charges and prepares goods for final shipment
  • Examines stock and distributes materials in inventory via Production Order pick lists and/or KanBan replenishment location/s in support of manufacturing requirements
  • Reviews MRP reports to assist in daily distribution requirements
  • Other duties as assigned

Experience:

  • 2+ years’ experience in shipping, receiving, inventory control and regulatory guidelines (GMP, ISO, FDA)
  • Proficient in MS Office, QAD and/or equivalent ERP systems
  • Forklift experienced and/or certified
  • Proficient with PLM systems (Arena, Agile, etc.)

Education: High school diploma or equivalent

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:

With minimal guidance from Senior Engineering Management, use 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 as appropriate.

Position Description and Responsibilities:

  • Must have strong, hands on development capability
  • Machining (milling and lathe)
  • Fixture design and assembly
  • Testing
  • Must have injection molding experience, including:
  • Part design for PIM process
  • Tooling design for reliable PIM processes
  • Knowledge of tooling fabrication process for optimal product design
  • Fundamental knowledge of optical theory and application is desired
  • Must have a fundamental knowledge of statistical tools for:
  • Tolerance analysis
  • Experiment design
  • 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
  • Write assembly process documents, test/experiment procedures, test and status reports
  • Participate in design reviews by generating review material and presenting design review material
  • Participate in generating intellectual property to protect the company’s technological position and build value of the company

Position Qualifications:

  • Mechanical engineering and solid modeling
  • CAD and CAM software
  • MS Suite
  • Matlab desired
  • Previous experience in high volume part design (plastic product design experience required)

Minimum Education:

  • BSME

Minimum Experience:

  • 2+ years applicable product design with BSME

Working Conditions:

Some travel (<10%) possible

Position Summary:

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 support the scale up and manufacturing of a high volume disposable medical device. This individual will be responsible for defining system requirements, automation and electrical standards, and managing the automation infrastructure and systems. Will develop project schedules, budgets and provide direct oversight and management of automation suppliers, machine OEM’s and service contractors, as well as driving the implementation and validation of manufacturing lines for Intuity products. This individual will 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. This individual will develop documentation (requirement specifications, drawings, qualification and validation reports) to support the automation lines and equipment. The individual will perform troubleshooting and implement process changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, documentation, and the implementation/validation of equipment and process changes

Position Description and 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.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Position 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 manage contractors
  • Ability to review design documents and set standards for machine builders and systems integrators
  • Service oriented mentality
  • Experience programming vision systems (Cognex)
  • Experience with databases
  • Experience with server management and virtualization
  • Excellent organizational, verbal and written communication skills as well as attention to details
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education:

  • Minimum of a BS in a related engineering discipline (mechanical, electrical, or chemical)

Minimum Experience:

  • 15 years experience in manufacturing and automation engineering

Working Conditions:

  • Travel required 20-30%

Supervised by:

  • Director of Manufacturing

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:

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:

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.

Product Development

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.

Quality Engineering

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.

Shift:
Swing shift

Summary of Primary Responsibilities:
Perform wide range of inspection of incoming purchased parts, raw material, assemblies, and subassemblies. Perform inspection of in-process, final assembly, and returned goods. Collaborate with Quality, Product Development and Manufacturing to address nonconformities.

Position Description and Responsibilities:

  • Perform and document detailed incoming inspections
  • Perform and document detailed first article inspections
  • Initiate Nonconforming Materials Reports and perform actions needed to determine product disposition, as required
  • Maintain and file inspection documentation (both hard and soft copies)
  • Maintain a clean and organized lab
  • Maintain an Inspection Log
  • Maintain IQC Lab Equipment/Fixtures:
    • Perform Preventive Maintenance when required (e.g., cleaning the equipment/fixtures)
    • Perform Calibration when required
    • Ensure equipment requiring outside calibration is turned into the calibration coordinator before the due date
    • Ensure equipment is properly labeled and identified
  • Maintain QC inspection sample retains
  • Provide input for inspection methods and improvements related to the job
  • Perform in-process, final assembly inspection, and returned goods inspection, as required
  • Perform other duties as assigned


Position Qualifications:

  • Ability to interpret engineering drawings (GD&T), receipt/shop travelers, purchase orders, procedures, bills of materials and supplier documentation
  • Ability to utilize various inspection tools (i.e., optical comparator or other vision inspection systems, micrometers, various gages, etc.)
  • Ability to manage workload to effectively and efficiently complete tasks within time constraints
  • Possess a strong work ethic, a positive attitude, good organization skills, and attention to detail
  • Act as a team member to identify and resolves issues
  • Familiar with ISO13485 and FDA QSR regulations
  • Knowledge of c= 0 and ANSI/ASQ Z1.4 Sampling Plans as it relates to verification activities
  • Competent computer and software application skills
  • Excellent verbal and written communication skills


Desirable Skills:

  • Experience with CMM PC-DMIS and OGP SmartScope Flash Software (MeasureMind) and/or Keyence Image Dimension Measuring System

Certificates Licenses and Registrations:

  • ASQ CQI (Certified Quality Inspector) preferred

Minimum Education/Experience:

  • AS or AA degree preferred
  • Minimum three (3) years of QA inspection experience in the medical device industry


Supervision:
  Supervised by Sr. Director, QA/RA

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 from
Monday to Friday 9:00AM to 9:00PM Eastern Time (ET)
to help answer your questions 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 from Monday to Friday 9:00AM to 9:00PM Eastern Time (ET) to help answer your questions 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 from Monday to Friday 9:00AM to 9:00PM Eastern Time (ET) to help answer your questions at 1-855-IMI-POGO (464-7646) or email us at support@presspogohelp.com

Background graphic image of POGO Automatic logo design