Lead Software Design Assurance Engineer

Job description

Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a Lead Software Design Assurance Engineer to play a critical role in driving compliance, innovation, and excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD). In this role, you’ll lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you’re an experienced professional with a strong background in software engineering, regulatory compliance, and mentoring, this is your opportunity to make a meaningful impact on healthcare innovation. Knowledge: Skills: Behaviors: Experience: - Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. - Expertise in Software Development Life Cycle (SDLC) for safety-critical applications, including Agile/iterative design controls. - Advanced knowledge of risk management frameworks (ISO 14971), including hazard analysis and FMEA. - Familiarity with usability engineering (IEC 6...