Design Quality Engineer - Medical Devices & Regulatory Compliance

Job Title:

Design Quality Engineer – Medical Devices

Location:

Bothell, WA
Work Mode:

Onsite
Client:

Tata Elxsi | Philips

Job Summary We are looking for a Design Quality Engineer (DQE) with experience in medical devices and FDA-regulated environments. The role involves supporting product quality throughout the design and development lifecycle, ensuring compliance with regulatory and quality standards.

Key Responsibilities Support Design Control activities as per FDA and ISO standards
Participate in design reviews, verification, and validation activities
Review design documents, technical files, and change requests (ECR/ECO)
Maintain traceability documentation including DHF, DMR, and DHR
Support design transfer activities to manufacturing
Drive Risk Management activities including FMEA and hazard analysis
Ensure implementation and documentation of risk controls
Support CAPA activities, root cause analysis, and audit readiness
Work closely with cross-functional teams including R&D, Manufacturing, and Regulatory
Required Skills & Experience5+ years of experience in FDA-regulated medical device environments
Strong knowledge of Design Control and Design Assurance processes

Experience with Risk Management and Design for Reliability
Familiarity with:21 CFR Part 820
ISO 13485
ISO 14971
EU MDR and other medical device regulations

Experience with change management and manufacturing transfer
Education Bachelor’s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field.