HeartFlow
Staff Systems Engineer (Plaque)
$190K–$250K
San Francisco, California +1 · Staff · Full-time · Posted Aug 13, 2026
- Location
- San Francisco, California
San Francisco - Experience
- 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
- Education
- B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline; Ph.D. preferred.
About the job
Leads systems engineering for coronary plaque analysis products, owning requirements, architecture, validation strategy, and accuracy standards in collaboration with clinical and engineering teams.
What you'll do
- Lead system architecture, integration, requirements, and verification and validation for plaque products.
- Define plaque ground truth and curate datasets to validate and improve measurement accuracy.
- Manage system risks and plaque-related complaints, and represent Systems Engineering in reviews, regulatory submissions, and audits.
What they ask for
- 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
- Hands-on experience with coronary plaque characterization and atherosclerosis imaging.
- Expertise in applied statistics, system design, requirements, measurement accuracy, and ground-truth strategies.
- Experience with FDA-regulated SaMD, design controls, and verification and validation supporting regulatory submissions.
Nice to have
- Quantitative plaque analysis, CCTA, and AI/ML-enabled clinical decision support experience.
- Familiarity with plaque reference methods (IVUS, OCT, histology), photon-counting or spectral CT, or imaging interoperability standards.
Pay
USD $190,000 to $250,000 base salary
Tools
FDA-regulated SaMD, CCTA, IVUS, OCT, DICOM, IHE, HL7/FHIR, PACS
AI focus
Systems engineering for AI/ML-enabled coronary plaque characterization and quantification, including defining accuracy standards and validation.
Model-written summary · the original posting is authoritative