Note: The job is a remote job and is open to candidates in USA. Capgemini Engineering provides engineering, software, and research and development services across industries. The Senior Design Quality Engineer will ensure end-to-end design quality and regulatory compliance for Class II/III medical devices, overseeing design controls, risk management, software development lifecycle activities, verification, validation, audits, and post-market processes.
Responsibilities
- 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)
Skills
- 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)
- 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
- Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
Benefits
- Hybrid work arrangement (minimum 3 days onsite) – Andover, MA OR Remote
- 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
- This role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws
Company Overview
Company H1B Sponsorship