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# Senior Design Quality Engineer- Medical Devices

- **Company:** Capgemini
- **Location:** Andover, MA, United States (Remote available)
- **Experience:** Expert
- **Salary:** $68,911.0 - $150,350.0
- **Contract:** Permanent contract
- **Skills:** Embedded Software, Failure Mode Effects Analysis, Systems Development Life Cycle, Verification and Validation (Software), Software Quality Assurance (SQA), Test Management, User-Centered Design, Software Verification, Documentation System, Information Technology
- **Published:** August 15, 2026
- **Apply:** https://www.capgemini.com/jobs/531392-en_US_SAPBTP/x/

## About the Role

* 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

## Description

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)


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