Principal Clinical Engineer – AI Performance & Investigations
Core
Lead end-to-end technical investigations for escalated or complex issues regarding Heartflow's AI/ML coronary artery disease products (FFRct, Plaque Analysis, PCI Navigator), determining root causes and driving corrective actions.
Role type
Principal Clinical Engineer (Post-Market Quality & Investigations)
Builds
Investigative reports, corrective and preventive actions (CAPAs), risk file updates, and product improvement feedback loops.
Domain
Medical Devices / Cardiovascular Imaging / AI/ML Software as a Medical Device (SaMD)
Deliverable
production ML models
Required skills
Complex technical investigation leadership, coronary CT angiography (CCTA) expertise, AI/ML SaMD anomaly management, regulatory compliance (FDA MDR, EU MDR, ISO 13485, ISO 14971), data analysis of logs and datasets, cross-functional partnership with R&D and Clinical Affairs, technical writing for regulatory scrutiny.
Preferred skills
Experience with invasive reference standards (IVUS, OCT), risk management (health hazard evaluations), mentoring first-line investigators.
Technologies
CCTA, FFRct, Plaque Analysis, PCI Navigator, AI/ML models, software version control, processing logs.
Responsibilities
Lead root cause analysis for alleged accuracy issues and software anomalies; reconstruct and analyze case-level evidence (CCTA inputs, model outputs); partner with R&D to reproduce issues and distinguish defects from expected performance; assess clinical significance with Medical Affairs; identify recurring failure modes and escalate potential signals; serve as SME for regulatory inspections and audits; establish advanced investigation methods and mentor staff; translate findings into actionable feedback for product development.
Seniority
Principal, hands-on IC with strategic influence