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 SummaryWe 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 ResponsibilitiesSupport 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 EducationBachelor’s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field. #J-18808-Ljbffr Tech Mirrors