Hiring: Sr. Software Developer Quality Engineer- Medical Devices Company: Capgemini Engineering Location: Burlington, VT Job Posted Time: 2026-09-16 15:57:07 Employment Type: Full-time / Remote Target Skills & Keywords : Agile, C, C#, C++, Change Management, Embedded Systems, Product Development Lifecycle, R, Risk Management, Root Cause Analysis, SAFe, Systems Engineering About the job Experience: •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 •Strong experience with complex medical systems for connected/embedded technologies •You’re able to share knowledge, insights regarding software quality standards, and regulatory requirements •You have excellent written and verbal communication skills, with the ability to communicate and present to all levels of management. Required Skills: •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. •Lead and oversee leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities •Lead and oversee leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement Qualifications: •Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!