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# Staff Design Quality Engineer

- **Company:** Stryker Corporation
- **Location:** Waltham, MA, United States
- **Experience:** Experienced
- **Salary:** $93,200.0 - $155,400.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Verification and Validation (Software), System Testing, 21 CFR Part 820 Quality System Regulation
- **Published:** October 23, 2026
- **Apply:** https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Waltham-Massachusetts/Staff-Design-Quality-Engineer_R575592

## About the Role

* 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.

Preferred

 * 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.

## Description

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 will 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.