New · posted Oct 25
Stryker · Medical Devices
Senior Design Quality Engineer (Mechanical)
- Portage, MI
- On-site
- Full-time
- Senior & Principal
The role
Work Flexibility: Onsite
Stryker is hiring a Senior Design Quality Engineer (Mechanical) in Portage, Michigan, to support our Medical business. In this role, you will independently execute and own quality engineering activities for defined mechanical workstreams within new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, and Regulatory, throughout the development process. You will be responsible for quality activities within assigned products, components, or suppliers, including risk management, design verification and validation, process controls, design transfer, and post-market quality support through the change control process. You may also contribute to and coordinate quality improvement initiatives within your assigned scope.
What you will need
- Bachelor’s Degree in Mechanical Engineering or a related engineering discipline.
- 2+ years’ experience in quality, manufacturing, new product development, or engineering.
What you need
Preferrednice to have
- Experience within the medical device or regulated manufacturing industry.
- Working knowledge of ISO 13485 and ISO 14971.
- Experience with statistical analysis, sampling plans, statistical process control, and Minitab.
- Applied knowledge of Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, tolerance analysis, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
- Ability to read and interpret CAD models, engineering drawings, specifications, and inspection requirements.
- Knowledge of polymer materials/processes and performance considerations for medical device applications.
- Six Sigma certification or ASQ certification.
What you'll do
- Partner with R&D to evaluate mechanical product designs against quality requirements for safety, effectiveness, reliability, manufacturability, and usability, and translate customer and market feedback into clear design and quality requirements for assigned workstreams.
- Own risk management deliverables for assigned new product development workstreams, including developing risk management plans and reports, facilitating risk reviews, and verifying the effectiveness of design and process risk controls.
- Execute and coordinate design quality activities for assigned workstreams across requirements, design reviews, drawings, specifications, inspection methods, design verification and validation, and change control to ensure objective evidence supports product acceptance.
- Develop and execute design verification and validation strategies and requirements, including usability activities; review protocols and results; and complete final reports with clear, statistically valid conclusions.
- Partner with Operations and suppliers to develop, evaluate and implement robust manufacturing process controls for assigned mechanical components and assemblies.
- Coordinate product design and quality transfers to internal and/or external manufacturing facilities, including PPAP planning, supplier communication, readiness reviews, and approval of quality documentation.
- Identify and document critical quality attributes within assigned workstreams using risk-based methods and ensure alignment with design outputs and process controls.
- Own PPAP execution for assigned components or suppliers. Communicate PPAP requirements to component suppliers, evaluate submission readiness, and approve PPAP documentation and results within the assigned scope.
- Support quality system maintenance and improvement by identifying procedural updates and implementing effective, sustainable solutions.
Pay
$77,700 – $129,500 a year
Employer providedUnited States of America Pay Ranges
- USN: $77,700 - $129,500 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Where 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: NoneStryker 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 · October 26, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Michigan14 roles publishing pay
Senior & Principal roles in the US319 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) | $103,250 | $119,000 | $139,000 |
This role: Stryker's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 26, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 921 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Career resources on Quality Assurance
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.
- Quality systems and risk8
- Documentation and SOPs5
- Lab testing and methods3
- Validation and qualification3
- Collaboration and leadership3
- GMP and compliance2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Stryker on Regulatory Jobs
- 66
- Open roles
- 54
- Distinct roles
- 18
- Locations
By discipline
- Quality54 82%
- Regulatory11 17%
- Compliance & Safety1 2%
By level
- Senior & Principal41 62%
- Associate & Specialist18 27%
- Manager7 11%
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Senior Design Quality Engineer (Mechanical) at Stryker
Open until filled. $78K–$130K a year, employer provided.