Design Quality Engineer

Role: Design Quality EngineerLocation: Bothell, WADuration: 12+ Months - OnsiteOur client is seeking an experienced Design Quality Engineer (DQE) to support product development and quality assurance activities within a highly regulated medical device environment. This onsite role will work closely with cross-functional teams including R&D, Manufacturing, Regulatory, and Suppliers to ensure products are designed, developed, and transferred to manufacturing in compliance with applicable regulatory and quality standards.The ideal candidate will have strong experience in Design Assurance, Design Controls, Risk Management, and Quality Systems within FDA-regulated medical device industries. Candidates with prior experience supporting MRI systems or superconducting magnet technologies are highly preferred.Key ResponsibilitiesEnsure compliance with Design Control requirements in accordance with 21 CFR Part 820, ISO 13485, and applicable regulatory standards throughout the product lifecycle.Participate in design planning, cross-functional design reviews, and design verification/validation (V&V) activities while ensuring closure of action items.Review and approve design inputs, design outputs, technical documentation, and engineering deliverables.Support creation and maintenance of Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and traceability matrices.Ensure Design Verification & Validation activities are properly executed and documented to meet quality and regulatory requirements.Review and approve Engineering Change Requests/Orders (ECR/ECOs) and ensure design changes follow established change control processes.Validate critical design inputs including usability, reliability, manufacturability, safety, and performance.Lead and support comprehensive risk management activities throughout the product lifecycle.Record, manage, and execute CAPA activities including root cause investigations and implementation of corrective/preventive actions.Contribute to the development, implementation, and continuous improvement of QMS processes and procedures.Provide guidance and mentorship to cross-functional teams on quality standards, compliance expectations, and best practices.Required Skills & ExperienceMinimum 5+ years of experience within FDA-regulated medical device environments with strong focus on Design Assurance and Design Controls.Strong understanding of: 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, Medical Device Design Controls & Risk ManagementExperience supporting: Design Verification & Validation (V&V), CAPA processes, Change Management, Design Transfer to Manufacturing, Engineering Change Control (ECR/ECO), FMEA and Hazard AnalysisDetailed experience supporting product defect prevention, design traceability, and Design for Reliability initiatives.Strong communication and collaboration skills with ability to work across cross-functional teams and suppliers.Prior experience supporting MRI systems or superconducting magnet technologies is highly preferred.EducationBachelor’s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field required.