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..
LocationHybrid (minimum 3 days onsite) – Andover, MA OR RemoteAbout the job you’re consideringCapgemini 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 roleServing 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 evidenceResponsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activitiesProviding quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk managementReviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readinessSupporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processesResponsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvementSupporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR).
Your skills and experienceBachelor’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 requirementsStrong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)Proven experience reviewing and improving SOPs or quality processes for regulatory complianceHands-on experience with software verification and validation using risk-based approaches aligned with FDA expectationsFamiliarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814).
Experience with test management, defect tracking, and quality documentation toolsStrong analytical, documentation, and stakeholder communication skills with ability to influence quality decisionsThe base compensation range for this role in the posted location is: 68,911
- 150,350Capgemini 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 not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.
S. and Canada, available benefits are determined by local policy and eligibility and may include:Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holi