Sr. Software Developer Quality Engineer in Burlington

At Capgemini Engineering, 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 provide unique R&D and engineering services across all industries. Join us for a career full of opportunities where you can make a difference.

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.
• 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).

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).
• 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.