{"schemaVersion":"jobsearcher.job.v1","id":"815ea9d68fa73dd6926f201d","url":"https://jobsearcher.com/jobs/815ea9d68fa73dd6926f201d","canonicalUrl":"https://jobsearcher.com/jobs/815ea9d68fa73dd6926f201d","title":"Design Quality Engineer","description":"Title : Role: Design Quality Engineer\nWork location: Bothell, WA & Cambridge MA 5 days on-site\nClient: TATA Elxsi-end client Philips.\nThe Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.\nDesign Control\nEnsure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle\nParticipate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items)\nReview and approve design inputs, outputs, and technical documentation.\nSupport traceability matrix (DHF, DMR, DHR) creation and maintenance.\nEnsure Design Verification & Validation (V&V) activities meet requirements\nReview and approve, Engineering Change requests/Orders (ECR/ECOs).\nEnsure design changes follow proper change control processes.\nBuilds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.\nValidates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.\nDesign transfer to manufacturing, ensuring process readiness\nRisk Management Support\nGuide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated\nFacilitate FMEA (Design and Process) and hazard analysis.\nEnsure risk controls are implemented, verified, and documented.\nQMS Support (Audit, CAPA)\nEnsure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance\nRecord, manage, and execute CAPA processes including root cause analysis and implementation of solutions\nContributes to the development, implementation, and revision of QMS processes\nMinimum required Education:\nBachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.\nMinimum required Experience:\nKnowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc\nChange Management (Including design and Manufacturing transfer)\nMinimum of 6+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk\nYou have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability\nPay: $88,599.67 - $100,000.00 per year\nWork Location: In person","company":"S Solutions","rawCompany":"s solutions","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-04T22:49:15.936Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Design Quality Engineer","description":"Title : Role: Design Quality Engineer\nWork location: Bothell, WA & Cambridge MA 5 days on-site\nClient: TATA Elxsi-end client Philips.\nThe Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.\nDesign Control\nEnsure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle\nParticipate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items)\nReview and approve design inputs, outputs, and technical documentation.\nSupport traceability matrix (DHF, DMR, DHR) creation and maintenance.\nEnsure Design Verification & Validation (V&V) activities meet requirements\nReview and approve, Engineering Change requests/Orders (ECR/ECOs).\nEnsure design changes follow proper change control processes.\nBuilds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.\nValidates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.\nDesign transfer to manufacturing, ensuring process readiness\nRisk Management Support\nGuide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated\nFacilitate FMEA (Design and Process) and hazard analysis.\nEnsure risk controls are implemented, verified, and documented.\nQMS Support (Audit, CAPA)\nEnsure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance\nRecord, manage, and execute CAPA processes including root cause analysis and implementation of solutions\nContributes to the development, implementation, and revision of QMS processes\nMinimum required Education:\nBachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.\nMinimum required Experience:\nKnowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc\nChange Management (Including design and Manufacturing transfer)\nMinimum of 6+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk\nYou have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability\nPay: $88,599.67 - $100,000.00 per year\nWork Location: In person","datePosted":"2026-08-04T22:49:15.936Z","dateModified":"2026-08-04T22:49:15.936Z","hiringOrganization":{"@type":"Organization","name":"S Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"815ea9d68fa73dd6926f201d"},"url":"https://jobsearcher.com/jobs/815ea9d68fa73dd6926f201d"}}