Enter a job title or keyword
Product Design Quality Engineer
Job Location:
Job Location:
Bothell, WA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
27 September 2026 (8 hours ago)
Posted:
Application Deadline:
25 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Summary :
This is a Product Design Quality / Design Quality Engineering role in the medical device / regulated product domain. The engineer will support the complete product lifecycle especially Design Control Design Verification & Validation (V&V) Risk Management CAPA RCA Process Validation PMS and regulatory compliance.
Roles & Responsibilities :
This is a Product Design Quality / Design Quality Engineering role in the medical device / regulated product domain. The engineer will support the complete product lifecycle especially Design Control Design Verification & Validation (V&V) Risk Management CAPA RCA Process Validation PMS and regulatory compliance.
Roles & Responsibilities :
- Manage the Design Control process from design inputs through verification validation and design transfer.
- Develop and execute process validation strategies using statistical/data-analysis methods.
- Prepare and maintain Quality Plans and other quality engineering documentation.
- Perform Design Verification (DV) and Design Validation (PV) planning and support execution.
- Review product/system designs for quality reliability safety performance and manufacturability.
- Perform Root Cause Analysis (RCA) for product and quality issues.
- Manage CAPA activities including investigation corrective action and effectiveness checks.
- Support Risk Management/Risk Assessment throughout the product lifecycle.
- Use Post-Market Surveillance (PMS) data to identify product quality issues and improvement opportunities.
- Work with R&D Manufacturing Regulatory Quality and external stakeholders.
- Bachelors or Masters degree in Mechanical Engineering Electronics Engineering Science or equivalent.
- Six Sigma Green Belt certification is preferred.
- Masters degree: No prior experience is specified as mandatory.
- Preferred experience includes Design Control Design Verification & Validation (DV/V) Process Validation Risk Management CAPA RCA PMS and medical-device/regulatory quality.
Required Experience:
IC
