Senior Design Quality Engineer Medical Devices | Onsite Location: USA (Bothell/Cambridge)| Contract

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Anagha Techno Soft, is seeking the following. Apply via Dice today!Job Title: Senior Design Quality Engineer Medical DevicesOnsite Location: USA (Bothell/Cambridge)Employment Type: ContractJob Summary:We are seeking an experienced Design Quality Engineer (DQE) with a strong background in FDA-regulated Medical Device environments. The ideal candidate will be responsible for ensuring products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role will collaborate closely with R&D, Manufacturing, Regulatory, and Supplier teams to embed quality throughout the product development lifecycle.Key Responsibilities:Design Control & Product DevelopmentEnsure compliance with Design Control requirements throughout the product lifecycle in accordance with FDA and ISO standardsParticipate in design planning, cross-functional design reviews, and verification/validation activitiesReview and approve design inputs, outputs, and technical documentationSupport creation and maintenance of traceability documentation including DHF, DMR, and DHRReview and approve Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)Ensure proper change control processes are followed for all design changesSupport Design Transfer activities to manufacturing and ensure process readinessValidate critical design inputs including usability, reliability, manufacturability, performance, and product safetyCollaborate with internal and external stakeholders to ensure alignment with quality and regulatory requirementsRisk ManagementFacilitate Design and Process FMEA activities and hazard analysisEnsure risk controls are identified, implemented, verified, and documentedSupport comprehensive risk management activities throughout the product lifecycleQuality Management System (QMS) SupportSupport quality audits and inspection readiness activitiesManage CAPA activities including root cause analysis and corrective/preventive actionsContribute to the development and continuous improvement of QMS processes and proceduresRequired Qualifications:Bachelor s Degree in Engineering, Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related fieldMinimum 5+ years of experience in FDA-regulated Medical Device environmentsStrong experience in Design Assurance, Design Control, and Risk ManagementHands-on experience with Change Management and Manufacturing Transfer processesStrong understanding of medical device regulations and standards including:21 CFR Part 820ISO 13485ISO 14971EU MDRMedical Device Directives and related global regulationsPreferred Skills:Design Quality & Reliability EngineeringRisk Management & FMEACAPA & Root Cause AnalysisDesign Verification & Validation (V&V)Product Traceability & DocumentationChange Control ManagementManufacturing TransferQuality Management Systems (QMS)Regulatory ComplianceCross-functional Collaboration