Senior Design Quality Engineer

Senior Design Quality Engineer (DQE)As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.Roles & Responsibilities: In this role you will play a key role in:Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidenceLeading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activitiesProviding quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk managementReviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readinessSupporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processesLeading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvementSupporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)Education & Experience:10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)Strong hands-on experience with design controls, DHF management, and traceability in regulated environmentsWorking knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)Experience supporting software quality within the SDLC and understanding of software risk management principlesProven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product developmentExperience supporting audits and regulatory submissions, with the ability to defend design and quality documentationStrong analytical, documentation, and communication skills with ability to work effectively across cross-functional teamsExperience with quality systems, eQMS/PLM tools, and defect/CAPA management processes10+ years of experience in software quality assurance within regulated environments (medical device preferred)Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirementsStrong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)Proven experience reviewing and improving SOPs or quality processes for regulatory complianceHands on experience with software verification and validation using risk-based approaches aligned with FDA expectationsFamiliarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)Experience with test management, defect tracking, and quality documentation toolsStrong analytical, documentation, and stakeholder communication skills with ability to influence quality decisionsBachelor's degree in Engineering (Biomedical, Software, Systems) or a related technical disciplineAdvanced degree (Masters) in Engineering, Quality, or Regulatory Affairs preferredRelevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus