> Markdown version of [/jobs/ext/3680155-software-developer-quality-engineer-medical-devices](https://www.wearedevelopers.com/jobs/ext/3680155-software-developer-quality-engineer-medical-devices). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Software Developer Quality Engineer- Medical Devices

- **Company:** Software, Inc.
- **Location:** Burlington, MA, United States
- **Experience:** Expert
- **Salary:** $68,911.0 - $150,350.0
- **Contract:** Permanent contract
- **Skills:** Agile Methodology, Systems Engineering, C Sharp (Programming Language), C++ (Programming Language), Software Quality, Computer Engineering, Failure Mode Effects Analysis, Object-Oriented Software Development, Software Architecture, Systems Development Life Cycle, Software Engineering, Verification and Validation (Software), User-Centered Design
- **Published:** October 11, 2026
- **Apply:** https://www.juju.com/job/1_capgemini2-1426707933

## About the Role

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 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.

## Description

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