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

Quality

Position Summary:

The Senior Quality Engineer is responsible for providing quality engineering support for manufacturing POGO meter and cartridges on a day-to-day basis to ensure regulatory compliance.

Duties and Responsibilities:

  • Work with Product Development, Operations and other departments to ensure regulatory compliance to POGO meter and cartridge manufacturing in accordance with 21CFR820 and ISO 13485.
  • Develop and execute Quality Engineering activities to meet commercial milestones
  • Support the analysis and evaluation of production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
  • Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical-to-quality attributes
  • Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
  • Participate in Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485, 21CFR 820 and IVDD.
  • Train and mentor team members on best practices in quality engineering and regulatory compliance.
  • Train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, DOE, and statistical methods.
  • Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
  • Assist in the development, improvement, and management of product assurance systems such as incoming quality inspection, in-process quality assurance, statistical process control, calibration / preventative maintenance, CAPA, nonconforming materials, product lot release testing, and finished goods control. 
  • Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.

Required Skills:

  • 7+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred. 
  • Strong reading, writing and speaking competency in English
  • Fluent in a wide variety of Quality tools such as Fishbone, 8D, 6S, 5 Why Analysis processes.
  • Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
  • Working knowledge of regulatory requirements such as QSR, ISO13485, and IVDD
  • Strong collaboration, team building and development skills
  • Strong written, verbal and interpersonal skills
  • Prior experience working in emerging, start-up companies desired 


Minimum Education:

  • B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience. 
  • ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor) or other relevant certification is highly desirable.

Engineering

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, tolerance, data analysis and other mechanical engineering principals will be employed.

Position Description and Responsibilities

  • Data and tolerance analysis to develop metrics to evaluate equipment and component improvements
  • Dimension parts and drawing using GD&T to improve tolerance stacks and yields
  • Support manufacturing equipment using both data and hands on observations
  • Hands-on, data collection, technical testing to develop test methods
  • Experiment and Process design and monitoring
  • Fixture design and development to improve efficiency and repeatability
  • Build planning and data analysis to ensure quality of component inventory
  • SPC implementation and evaluation of value add
  • NCR investigations
  • WI revision and monitoring
  • Power point summaries of project progress and document/data organization
  • Continuous improvement of testing and measurement methods to increase accuracy and throughput 
  • Write and execute technical protocols, IQ/OQ/PQ’s for manufacturing and injection molding processes
  • Generate project timelines and reliably execute to timelines using the available resources
  • Perform root cause analysis on manufacturing defects and field return product
  • Perform design verification testing using engineering lab equipment such as push/pull tester, flow meter, sound meter, high speed video and metrology equipment.

Position Qualifications:

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

PC Tools: MS Office Suite, Matlab

Statistical Analysis: JMP, Minitab, DOE, Gauge R&R

Minimum Education:

BS Engineering

Minimum Experience

7+ years

Finance

Summary of Primary Responsibilities

The FP&A Manager is a key, executive-facing role that will report directly to the VP of Finance, and support Intuity’s continued growth as a commercial-stage medical device company. This role will partner with business leaders across Sales Operations, Manufacturing and Product Development organizations to develop annual budgets and multi-year forecasts. This role will monitor results and provide insight of key business drivers. Success in this role will require cultivating partnerships across teams, understanding the business and sales channels, have strong communication skills, and strategic thinking skills to drive value to the business.

Position Description and Responsibilities

  • Coordinate and collaborate with other departments within the organization, such as Sales Operations, Manufacturing and Product Development, to further understand business objectives.
  • Manage and participate in the budget and forecasting process by assisting with the formulation and collection of key assumptions, preparing facility-level budgets, and analyzing results, including revenue by various distribution channels (tradition brick-and-mortar pharmacy, direct-to-consumer, online pharmacy), operating expenditures, capital expenditures and headcount needs.
  • Work with management to leverage external data to understand, interpret and challenge revenue and expense projections for short- and long-term financial models.
  • Maintain excel models that serve as the primary source of entity-level financial projections
  • Collaborate with leaders to deliver monthly reporting dashboards of key financial and performance metrics.
  • Maintain gross-to-net revenue pricing models.
  • Perform budget versus actual analysis at the consolidated and departmental levels to identify and understand variances, assess risks and opportunities, generate insights and communicate results to senior management.
  • Responsible for reviewing and approving purchase orders for compliance with budget and accounting rules.
  • Assist with due diligence process for financing events.
  • Additional ad hoc requests as needed.

Experience and Requirements:

  • 6+ years of increasing responsibility in financial analyses and accounting related roles.
  • Professional experience in a medical device, pharmaceutical, or biotechnology organization preferred.
  • Ability to establish strong business relationships and interact cross-functionally at all levels.
  • Must possess strong problem-solving skills. Ability to work effectively to identify issues, gather relevant data points and generate insights and solutions.
  • Must be a strong communicator capable of explaining/presenting complex financial concepts and problems clearly and effectively to all constituents.
  • Customer service oriented; able to understand business requirements while maintaining ownership for projects and results.
  • Highly detail oriented with strong analytical skills; experienced in developing financial models, leading analysis, and explaining options and implications.
  • Highly motivated self-starter capable of working under pressure and prioritizing workload to meet deadlines.
  • Strong team player with ability to demonstrate executive presence.
  • Process and systems improvement mindset for creating solutions to problems that work across boundaries beyond this role.
  • Technical accounting proficiency preferred.
  • Experience with QAD ERP system preferred.

Minimum Education:

  • A Bachelor’s degree in finance or accounting required
  • CPA, CFA and/or MBA preferred

Intuity Medical, Inc. 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.