Principal Clinical Engineer – AI Performance & Investigations

Location: San Francisco, California; hybrid work

Base salary: $188,000–$240,000 per year, plus cash bonus and equity.

Company

hirify.global develops AI-driven, non-invasive cardiac imaging and analysis products for diagnosing and managing coronary artery disease.

What you will do

• Lead end-to-end technical investigations of complex issues in AI/ML-enabled SaMD products, including FFRCT Analysis, Plaque Analysis, and PCI Navigator.
• Reconstruct case-level evidence from CCTA inputs, model outputs, processing logs, analyst workflows, and software version history to determine root causes.
• Partner with Research, Software, Systems Engineering, Medical Affairs, Clinical Affairs, Regulatory Affairs, and Quality to reproduce issues and assess clinical impact.
• Identify recurring failure modes and support nonconformances, CAPAs, risk-file updates, health hazard evaluations, and field action assessments.
• Provide technical input for FDA MDR, EU MDR vigilance, PMDA, QMSR, ISO 13485, and regulatory inspection activities.
• Improve investigation methods and tools, evaluate AI-assisted approaches, mentor first-line investigators, and feed findings into product development.

Requirements

• 12+ years of experience in medical devices or regulated imaging products, including engineering, investigation, or post-market quality work.
• Hands-on experience with coronary CT, CCTA, coronary plaque characterization, or atherosclerosis imaging.
• Experience leading complex cross-functional investigations through root cause and documented conclusion.
• Working knowledge of complaint handling, MDR/vigilance, CAPA, risk management, FDA 21 CFR Parts 803 and 820, ISO 13485, ISO 14971, EU MDR, and IEC 62304.
• Experience investigating software or SaMD products, preferably AI/ML-based devices, with strong data analysis, technical writing, and communication skills.
• B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline.

Nice to have

• Experience with cardiovascular imaging, FFR/FFRCT, quantitative plaque analysis, invasive FFR, IVUS, or OCT.
• Advanced degree, such as a Ph.D. or clinical degree.
• Experience with health hazard evaluations and field actions.

Culture & Benefits

• Opportunity to contribute to AI-driven cardiac care products used internationally.
• Cash bonus and equity in addition to base salary.
• Occasional domestic and international travel is required.
• Work environment focused on collaboration across engineering, clinical, medical, regulatory, and quality functions.