Senior Design Quality Engineer- Medical Devices

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries.

About The Role

Capgemini Engineering is seeking a Senior Design Quality Engineer for 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.

Responsibilities

• Serve 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).
• Establish and maintain DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence.
• Lead and maintain risk management activities (hazard analysis, FMEA, risk files) and ensure integration of risk controls into design and validation activities.
• Provide quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management.
• Review and approve design, software, and validation deliverables to ensure completeness, consistency, and audit readiness.
• Support verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes.
• Lead or support CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement.
• Support internal and external audits (FDA, Notified Body, ISO), and contribute to regulatory submissions (e.g., IDE, PMA, EU MDR).

Requirements

• 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).
• Embedded development or Digital Platform background, or exposure to embedded development/Digital Platform within the Medical Devices domain (preference for 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.

Schedule

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

Pay

The base compensation range for this role in the posted location is $68,911 - $150,350. Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The actual compensation offered may fall outside of the posted range and will be determined based on factors such as geographic location, education, certifications, relevant experience, skills, seniority, performance, market considerations, and internal pay equity.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation (12-25 days, depending on grade), Company paid holidays, Personal Days, Sick Leave.
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada).
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada).
• Life and disability insurance.
• Employee assistance programs.
• Other benefits as provided by local policy and eligibility.