Staff Systems Engineer (Plaque)

The role

You will be the technical lead for Heartflow's plaque analysis products. You will own system requirements, architecture, and verification and validation strategy for coronary plaque detection, characterization, and quantification.

What you will do

• Lead Systems Engineering for plaque analysis products including concept definition, architecture, interface definition, integration, and V&V.
• Translate plaque biology and clinical utility into testable requirements.
• Identify, analyze, and manage system-level technical risks.
• Collaborate with cross-functional teams to drive requirements and characterization activities.
• Define and own the plaque ground truth with the Clinical team.
• Curate plaque datasets to improve accuracy and validation.
• Serve as primary investigator for plaque-related complaints and escalations.
• Represent Systems Engineering in design reviews, program planning, and regulatory submissions.
• Promote Systems Engineering best practices and mentor Systems Engineers.

Required qualifications

• 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
• Direct, hands-on experience with coronary plaque characterization and atherosclerosis imaging.
• Expertise in applied statistics for quantifying plaque measurement accuracy and performance.
• Proficiency in system design, interface definition, requirements writing, and ground-truth strategies.
• Demonstrated ownership of system requirements, traceability, and V&V for regulatory submissions.
• Working knowledge of design control, quality, risk, and software lifecycle requirements (FDA, EU MDR, PMDA).
• Experience developing FDA-regulated SaMD.
• Strong written and verbal communication skills.
• B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline.

Nice to have

• Ph.D.
• Experience with quantitative plaque analysis, coronary CT angiography (CCTA), and AI/ML-enabled clinical decision support.
• Familiarity with plaque ground-truth and reference-standard methods (e.g., IVUS, OCT, histology).
• Experience applying photon-counting or spectral CT to plaque characterization.
• Expertise in imaging performance and accuracy validation, including relevant statistical methods.
• Expertise in DICOM and medical imaging interoperability standards (e.g., IHE, HL7/FHIR, PACS integration).

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The company is publicly traded (HTFL) and provides an AI-driven, non-invasive cardiac test.