Principal Clinical Engineer – AI Performance & Investigations

The role

You will lead and resolve escalated or complex technical investigations for AI/ML coronary artery disease products. You will partner with Research, Software Engineering, Product Management, and Medical and Clinical Affairs teams to determine root causes and drive corrective actions.

What you will do

• Lead end-to-end technical investigations of AI/ML-enabled SaMD products
• Reconstruct and analyze case-level evidence to establish root causes
• Partner with Research, Software, and Systems Engineering to reproduce issues
• Partner with Medical and Clinical Affairs to assess clinical significance
• Identify recurring failure modes and emerging trends
• Support health hazard evaluations and field action assessments
• Serve as a subject matter expert for regulatory inspections and audits
• Establish and improve advanced investigation methods and tools
• Provide technical input to Complaint Handling and Regulatory Affairs
• Author investigation reports that meet FDA and ISO requirements

Required qualifications

• 12+ years of experience in medical devices and/or regulated imaging products
• Direct, hands-on experience with coronary CT, including CCTA, coronary plaque characterization, or atherosclerosis imaging
• Background as an R&D, Systems, or Quality Engineer, or in a clinical role, working with imaging medical devices
• Demonstrated experience leading complex, cross-functional technical investigations
• Working knowledge of complaint handling, MDR/vigilance reporting, CAPA, and risk management requirements
• Experience investigating issues in software or SaMD products
• Comfort with data analysis to interrogate logs, outputs, and datasets
• Ability to engage with engineers and clinicians across cross-functional teams
• Excellent technical writing and communication skills
• Ability to communicate investigation conclusions to executive management
• B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline

Nice to have

• Advanced degree (e.g., Ph.D. or clinical degree)
• Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis
• Experience investigating performance of AI/ML-enabled medical devices
• Familiarity with invasive reference standards (e.g., invasive FFR, IVUS, OCT)
• Experience with risk management, including supporting health hazard evaluations and field actions

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The company is a publicly traded company (HTFL) that provides an AI-driven, non-invasive cardiac test.