Senior Design Quality Engineer- Medical Devices

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Location

Hybrid (minimum 3 days onsite) – Andover, MA OR Remote

About the job you’re considering

Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. 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.

Your role

• Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) 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 evidence
• Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
• Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
• Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
• Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
• Responsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
• Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

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Your skills and experience

• Bachelor’s degree in business, Engineering, Project Management, Computer Science, or a related discipline.
• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
• Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
• Hands-on experience with software verification and validation using risk-based approaches aligned with FDA expectations
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814).
• Experience with test management, defect tracking, and quality documentation tools
• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions