Lead Engineer, AI/ML SaMD Investigations

Begell House Inc.; South San Francisco (CA); On-site; USD 188,000 - 240,000; Full time

Job summary

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

Qualifications

• S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline.
• Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
• Experience investigating performance of AI/ML-enabled medical devices.

Responsibilities

• Lead end-to-end technical investigations of Heartflow's AI/ML SaMD products, including accuracy issues and software anomalies.
• Reconstruct and analyze case-level evidence to establish root causes and drive corrective actions.
• Collaborate with R&D, Software, and Medical Affairs to reproduce issues and differentiate defects from expected performance.
• Assess clinical significance and document rationale for regulatory reports.
• Support CAPAs, nonconformances, and risk file updates per ISO 14971 and MDR requirements.

Skills

Medical devices

Regulatory reporting

MDR/Vigilance

CAPA

ISO 13485

IEC 62304

AI/ML SaMD

Root cause analysis

Technical writing

Cross-functional collaboration

Education

S. in Biomedical Engineering, Electrical Engineering, CS, Physics or related

Job description

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