Senior Engineer, Advanced Quality
Portage, MI
Join a role focused on leading quality engineering activities within new product development projects for medical devices. This position supports the integration of quality processes, risk management, and regulatory requirements throughout the design and manufacturing lifecycle. You will work cross-functionally to ensure product and process quality meet internal standards and external regulations.
Work Flexibility:
Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.
What You Will Do
- Lead quality activities for new product development projects, ensuring alignment with quality systems and regulatory requirements
- Develop and maintain quality documentation, including design history files, verification and validation reports, and risk management records
- Define and support verification and validation strategies, ensuring objective evidence meets acceptance criteria
- Conduct risk management activities, including developing risk plans, performing risk analysis, and verifying mitigation effectiveness
- Analyze quality data using statistical methods to establish acceptance criteria, process parameters, and resolve quality issues
- Collaborating with Engineering, Manufacturing, Regulatory, and Operations to support design reviews and product development milestones
- Develop and approve inspection plans, product drawings, and manufacturing documentation for new products
- Support product transfers to manufacturing and participate in audit readiness and regulatory interactions
What You Will Need
Required
- Bachelor’s degree in Engineering, Science, or related discipline
- Minimum 2 years of experience working in a regulated environment
- Experience applying quality principles such as CAPA, audit processes, and statistical analysis
- Experience supporting design control, risk management, and validation activities
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
Preferred
- Experience in medical device product development lifecycle
- Certification such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Green/Black Belt
- Experience applying advanced quality tools (e.g., FMEA, root cause analysis, mistake-proofing)
- $77,700 - $129,500 USD Annual
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
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What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
