Note: The job is a remote job and is open to candidates in USA. Capgemini Engineering is hiring a Senior Design Quality Engineer for medical devices. The role ensures end-to-end design quality and regulatory compliance across the development lifecycle of Class II/III medical devices, including software-driven and active implantable products, and supports design controls, risk management, audits, 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

• 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
• You have 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
• You're 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 quality and design control documentation
• You have 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

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

Company Overview

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