New · posted Nov 9
Stryker · Medical Devices
Senior Engineer, Advanced Quality
- Portage, MI
- On-site
- Full-time
- Senior & Principal
The role
Work Flexibility: Hybrid or Onsite
Stryker is hiring a Senior Engineer, Advanced Quality for our Instruments (Neurosurgical) division. This is an onsite role based in Portage, MI.
As the Senior Engineer, Advanced Quality you will support quality engineering throughout new product development. In this role, you will lead design quality activities across risk management, reliability engineering, human factors, design verification and validation, and process validation while partnering with Engineering, Manufacturing, and Product Development teams to ensure products meet applicable quality and regulatory requirements.
What you need
Required
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Science, or a related discipline.
- Minimum 2 years of full-time work experience in Quality Engineering, Technical Engineering, Product Development, or a related engineering role within a research and development or manufacturing environment.
- Experience applying quality engineering methods within product development or manufacturing processes.
Preferrednice to have
- Minimum 1 year of experience in Advanced Quality Engineering, Design Quality Engineering, or a related new product development quality role.
- Experience working within a regulated medical device or other regulated manufacturing environment.
- Experience applying ISO 13485, Good Manufacturing Practice, and Good Documentation Practice requirements.
- American Society for Quality Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), or equivalent training or experience.
- Training or certification in Geometric Dimensioning and Tolerancing (GD&T).
- USN: $77,700 - $129,500 USD Annual
What you'll do
- Lead quality engineering activities for new product development, ensuring compliance with FDA Quality System requirements, ISO 13485, and internal quality standards.
- Lead product risk management activities, including risk analysis, failure mode evaluation, risk mitigation, and assessment of product reliability.
- Apply quality engineering tools and statistical methods to evaluate components, assemblies, processes, and finished products throughout design and development.
- Lead human factors engineering and design validation activities to verify products meet defined user needs, intended uses, and safety requirements.
- Develop reliability testing strategies, including accelerated test methods and correlation of test results with expected field performance.
- Support design verification, process validation, manufacturing process development, and inspection methods for components and finished products.
- Partner with Research & Development, Manufacturing, Product Engineering, and other cross-functional teams to review technical deliverables and resolve quality issues throughout development.
- Support nonconformance and corrective and preventive action investigations using structured problem-solving, root cause analysis, and appropriate corrective action methods.
Pay
$77,700 – $129,500 a year
Employer providedWhere you'll work
Portage, MIOn-siteOpen in Maps (opens in a new tab)
More jobs in Portage, MIEqual opportunity, accessibility and legal noticesStryker's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Michigan6 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $77,700 | — | $129,500 |
| Michigan (middle half) | $104,000 | $111,500 | $119,000 |
| All US (middle half) | $114,500 | $128,000 | $135,000 |
This role: Stryker's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 74 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Lab testing and methods6
- Quality systems and risk4
- GMP and compliance3
- Validation and qualification3
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ASTMASTM F1980(official source, opens in a new tab)Accelerated aging of sterile barrier systems and medical devices
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
Company hiring pulse
Stryker on Regulatory Jobs
- 68
- Open roles
- 68
- Distinct roles
- 17
- Locations
By discipline
- Quality53 76%
- Regulatory12 17%
- Clinical5 7%
By level
- Senior & Principal39 56%
- Associate & Specialist23 33%
- Manager8 11%
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Senior Engineer, Advanced Quality at Stryker
Open until filled. $78K–$130K a year, employer provided.