Senior SaMD Quality Engineer - AI/ML & Regulatory Leader
HeartFlow
Heartflow in San Francisco is advancing AI-driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME for software quality and design excellence, aligning Agile development with medical device regulations across the SDLC. Lead design control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR; mentor R&D, Product, and Program teams; drive compliance at speed in a regulated environment. #J-18808-Ljbffr
Vacancy posted 3 days ago
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