Lead Engineer, AI/ML SaMD Investigations

Posted 6 days ago

begell houseSouth San Francisco (CA)

Cardiologists Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Lead

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About the role

Heartflow is a medical technology company advancing non-invasive cardiac care with AI-driven insights. We seek a Principal Engineer to lead complex post-market investigations for our AI/ML SaMD products, collaborating across R&D, Medical, Regulatory, and Quality to identify root causes and drive corrective actions. You will analyze case evidence, test hypotheses, and help ensure medical device regulatory compliance, including FDA and EU MDR considerations, while communicating findings clearly to

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