Principal Engineer, AI/ML SaMD Investigations

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

Job summary

HeartFlow, Inc. seeks a Principal Engineer - Product Investigations to lead escalated technical investigations for AI/ML coronary artery disease products, including FFRct Analysis and Plaque Analysis.

You will partner across R&D, Medical, Clinical, Regulatory, and Quality to determine root causes, drive corrective actions, and guide product improvements while reporting to the Director of Post-Market Quality. Occasional travel may be required.

Qualifications

• 12+ years in medical devices or regulated imaging products.
• Experience with coronary CT/CCTA or plaque analysis is required.
• Background in R&D, Systems, or Quality Engineering in imaging devices.
• Proven record leading cross-functional investigations to root cause.

Responsibilities

• Lead end-to-end technical investigations of AI/ML-enabled SaMD products.
• Reconstruct and analyze case-level evidence to establish root causes and preventive actions.
• Collaborate with Research, Software, and Systems Engineering to reproduce issues and test hypotheses.
• Assess clinical significance and patient impact with Medical Affairs, and document rationale.

Skills

Medical devices

Investigations leadership

MDR/vigilance

AI/ML SaMD

IEC 62304 familiarity

Data analysis

Cross-functional collaboration

Regulatory inspections

Technical writing

Clinical interpretation

Education

BSc/MSc in Biomedical Eng/Electrical Eng/CS/Physics

Job description

HeartFlow, Inc. seeks a Principal Engineer - Product Investigations to lead escalated technical investigations for AI/ML coronary artery disease products, including FFRct Analysis and Plaque Analysis.

You will partner across R&D, Medical, Clinical, Regulatory, and Quality to determine root causes, drive corrective actions, and guide product improvements while reporting to the Director of Post-Market Quality. Occasional travel may be required.