Senior Software Quality Engineer

Summary

The Senior Software Quality Engineer drives quality and compliance for embedded firmware development in medical devices, collaborating across R&D, Regulatory, and Quality teams. Responsibilities include leading FMEA and hazard analysis, managing design controls and risk management, triaging software issues, conducting design reviews, and ensuring requirement traceability and standards compliance (IEC 62304, 13485, 14971, FDA QMSR). The role requires 4+ years in Quality/Engineering/Software Development (or 2+ with an advanced degree) and strong communication across organizational levels.