Sr. Software Developer 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. 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 posted location is: 68,Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting.

This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are…