Principal Engineer - Product Investigations (AI/ML)

Location: San Francisco, California; hybrid

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

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive cardiac imaging and analysis products for coronary artery disease.

What you will do

• Lead end-to-end technical investigations of escalated complaints and post-market issues involving AI/ML-enabled SaMD products, including FFRCT Analysis, Plaque Analysis, and PCI Navigator.
• Reconstruct and analyze 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, Product Management, Regulatory, and Quality teams 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, audits, inspections, and regulatory reportability decisions.
• Improve investigation methods and tools, evaluate AI-assisted investigation approaches, mentor first-line investigators, and translate findings into product improvements.

Requirements

• 12+ years of experience in medical devices and/or regulated imaging products, including engineering, investigation, or post-market quality work.
• Hands-on experience with coronary CT, CT angiography, coronary plaque characterization, or atherosclerosis imaging.
• Background as an R&D, Systems, Quality, or clinical professional working with imaging medical devices.
• Experience leading complex cross-functional investigations through root cause and documented conclusion, with strong technical writing and communication skills.
• Working knowledge of complaint handling, MDR/vigilance, CAPA, risk management, 21 CFR Parts 803 and 820, ISO 13485, ISO 14971, EU MDR, and IEC 62304.
• Bachelor’s or master’s degree in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline; occasional domestic and international travel is required.

Nice to have

• Experience with cardiovascular imaging, FFR/FFRCT, quantitative plaque analysis, or AI/ML-enabled medical devices.
• Familiarity with invasive reference standards such as invasive FFR, IVUS, or OCT.
• Advanced degree, clinical degree, risk management experience, health hazard evaluations, or field actions experience.

Culture & Benefits

• Work in a hybrid environment with occasional domestic and international travel.
• Compensation includes base salary, cash bonus, and equity.
• Collaborate across research, engineering, product, medical, clinical, regulatory, and quality functions.
• Contribute to products used in coronary artery disease diagnosis and management.