Senior Design Quality Engineer- Medical Devices

# Senior Design Quality Engineer
- Medical Devices Burlington Apply  for this job
* Permanent* Experienced Professionals
* Software Engineering* - 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. Join us for a career full of opportunities.

Where you can make a difference. Where no two days are the same. ## .
** 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)## .
** 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

The base compensation range for this role in the…