Heartflow - Principal Clinical Engineer – AI Performance & Investigations
Requirements
• 12+ years of experience in medical devices and/or regulated imaging products, with substantial time in engineering, investigation, or post-market quality roles. • Direct, hands-on experience with coronary CT, including CT angiography (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 through to root cause and documented conclusion. • Working knowledge of complaint handling, MDR/vigilance reporting, CAPA, and risk management requirements (21 CFR Parts 803 and 820, ISO 13485, ISO 14971, EU MDR). • Experience investigating issues in software or SaMD products, ideally in AI/ML-based devices, with working familiarity with the software lifecycle and anomaly management (IEC 62304). • Comfort with data analysis to interrogate logs, outputs, and datasets and to quantify performance against expectations. • Ability to engage credibly with engineers and clinicians across cross-functional teams, understanding technical details while framing findings in terms of clinical meaning. • Excellent technical writing and communication skills; track record of investigation reports that withstand regulatory review. • Ability to communicate investigation conclusions, risks, and recommended actions clearly and concisely to executive management. • Educational Requirements & Work Experience • B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline; advanced degree (e.g., Ph.D. or clinical degree) preferred. • Occasional domestic and international travel required. • How You Stand Out • 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.
Responsibilities
• Lead end-to-end technical investigations of products involving Heartflow's AI/ML-enabled SaMD products, including alleged accuracy issues, discrepancies with invasive or reference measurements, and software anomalies. • Reconstruct and analyze case-level evidence, including CCTA inputs, model outputs, processing logs, case analyst workflow records, and software version history, to establish robust root cause(s) and recommend corrective and preventive actions. • Partner with Research, Software, and Systems Engineering to reproduce issues, test hypotheses, and distinguish product defects from expected performance, input limitations, and use-related factors. • Partner with Medical and Clinical Affairs to assess clinical significance and potential patient impact, and document the clinical rationale in each escalated investigation. • Identify recurring failure modes, themes, and emerging trends across investigations; escalate potential signals; and initiate or support nonconformances, CAPAs, and risk file updates in line with ISO 14971. • Support health hazard evaluations and field action assessments when investigations indicate a potential systemic issue. • Serve as a subject matter expert for complex technical investigations in regulatory inspections, audits, and cross-functional reviews. • Establish and improve advanced investigation methods, templates, and tools, including evaluating AI-assisted investigation approaches, and mentor first-line Product Investigators on complex case handling. • Provide expert technical input to Complaint Handling and Regulatory Affairs to support timely reportability determinations under FDA MDR (21 CFR Part 803), EU MDR vigilance, and other global requirements (e.g., PMDA). • Author investigation reports that meet FDA QMSR (21 CFR Part 820) and ISO 13485 requirements and withstand scrutiny in FDA inspections, Notified Body audits, and internal audits. • Translate investigation findings into actionable feedback for R&D and product development teams, including anomaly reports, requirements gaps, and product improvement recommendations, and follow through to verified resolution.
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