Sr. Software Developer Quality Engineer- Medical Devices

About the role

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.

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 and Experience

• Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
• 10+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong understanding of QMS supporting Software Design Controls.
• Proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe
• Experience participating in software design reviews, software architecture reviews, and assessment of software lifecycle deliverables including requirements, architecture/design documentation, traceability, verification, and validation evidence
• Strong experience with complex medical systems for connected/embedded technologies
• Able to share knowledge, insights regarding software quality standards, and regulatory requirements
• Experience supporting software-related regulatory submissions and audits (e.g., IDE, PMA, 510(k), EU MDR) and defending software) and defending software quality and design control documentation
• Excellent written and verbal communication skills, with the ability to communicate and present to all levels of management.
• Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.

Pay

The base compensation range for this role is $68,911 - $150,350.

Benefits

• 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
• Other benefits as provided by local policy and eligibility

Schedule

Hybrid (minimum 3 days onsite) – Andover, MA OR Remote