Staff Device Quality Engineer

Staff Device Quality Engineer responsible for serving as the senior technical authority on software quality and design excellence across multiple Heartflow product lines and platform initiatives. Lead end-to-end design control within the Software Development Lifecycle (SDLC) to ensure software architecture, security, and global regulatory requirements are integrated into every release. Drive risk management activities (Hazard Analysis, FTA, Software FMEAs), establish V&V strategy and execution, and own DHF documentation and regulatory submissions. Own audits and regulatory readiness (FDA, Notified Bodies, MDSAP), mentor R&D and Product teams on quality-by-design practices, and influence product strategy and roadmaps. Act as a program-level leader for QA strategy, quality systems (QMS) governance, and cross-functional collaboration to ensure SaMD and AI/ML-based solutions are safe, secure, and compliant across global markets.