Senior Design Quality Engineer

Capgemini • Burlington, MA

5d • $73,150 - $146,300 • Hybrid

About The Position

Capgemini Engineering is actively looking for a Senior Design Quality Engineer with senior QA experience who will serve 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).

Requirements

• 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 environments
• Working 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 principles
• Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
• Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
• Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
• Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

Responsibilities

• 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 evidence
• 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
• 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)

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life insurance
• Disability insurance
• Employee assistance programs
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed