New · posted Oct 23
Stryker · Medical Devices
Staff Design Quality Engineer
- Waltham, MA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
Work Flexibility: Hybrid
Waltham – MA
Join Stryker as a Staff Design Quality Engineer supporting new product development and quality activities throughout the medical device product lifecycle. In this role, you will partner with Research & Development, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to support design controls, risk management, product verification and validation, design transfer, and Quality Management System compliance in a regulated medical device environment.
Work Flexibility
Hybrid: candidates must reside within commuting distance of Waltham – MA and be able to work onsite several days per week.
What you need
Required
- Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
- Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related position within the medical device industry.
- Experience supporting new product development, including design control activities.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, design controls, corrective and preventive action, change management, and process validation.
- Experience using electronic Quality Management Systems.
Preferrednice to have
- Certified Quality Engineer (CQE) certification or a comparable quality certification.
- Experience with Class II and/or Class III medical devices, including global requirements such as the European Union Medical Device Regulation and Medical Device Single Audit Program.
- Experience with statistical analysis, quality improvement methodologies, supplier quality management, auditing, software validation, or computerized system validation.
US20: $93,200 - $155,400 USD Annual
What you'll do
- Represent Quality Engineering on cross-functional new product development teams, providing quality and regulatory guidance throughout the product lifecycle.
- Review and approve design control documentation, including design plans, user needs, design inputs and outputs, verification and validation protocols and reports, design reviews, and Design History File documentation.
- Apply risk management principles in accordance with ISO 14971 and participate in design reviews and product risk assessments.
- Support verification, validation, process validation, and design transfer activities to ensure established requirements and acceptance criteria are addressed.
- Evaluate product requirements, specifications, engineering changes, and manufacturing changes for quality and regulatory impact.
- Investigate product and development issues using root cause analysis and support corrective and preventive actions, nonconformances, change control, and complaint investigations.
- Maintain quality documentation and records in accordance with ISO 13485, FDA 21 CFR Part 820, and applicable global medical device requirements.
- Support internal and regulatory audits, supplier quality activities, regulatory submissions, and updates to quality procedures, work instructions, and quality system requirements.
Pay
$93,200 – $155,400 a year
Employer providedWhere you'll work
Waltham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Waltham, MAEqual 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 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts27 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $93,200 | — | $155,400 |
| Massachusetts (middle half) | $106,250 | $124,000 | $133,000 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
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 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 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
- GMP and compliance6
- Validation and qualification5
- Documentation and SOPs3
- Lab testing and methods1
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
- Collaboration and leadership1
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.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Stryker on Regulatory Jobs
- 66
- Open roles
- 54
- Distinct roles
- 18
- Locations
By discipline
- Quality53 80%
- Regulatory11 17%
- Compliance & Safety2 3%
By level
- Senior & Principal40 61%
- Associate & Specialist19 29%
- Manager7 11%
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Staff Design Quality Engineer at Stryker
Open until filled. $93K–$155K a year, employer provided.