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HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship products—FFR_CT Analysis, RoadMap Analysis, and Plaque Analysis—use advanced AI to create 3D models of coronary arteries and assess blood flow impact, helping clinicians identify and manage stenoses. These solutions are cleared in the US, UK, Europe, Japan, and Canada, and have been used by over 500,000 patients worldwide.
As Staff Systems Engineer for Plaque Analysis, you will be the technical leader for HeartFlow's plaque characterization and quantification products. Reporting to the Sr. Director of Systems Engineering, you own system requirements, architecture, and verification & validation (V&V) strategy for plaque detection and measurement. You will define the ground truth standards against which plaque products are validated and set the accuracy benchmarks for the field.
Key responsibilities include: leading systems engineering across concept, architecture, interface definition, and product integration; translating plaque biology and clinical needs into rigorous, testable requirements; identifying and managing system-level technical risks using data-driven approaches; collaborating with Clinical, Research, Product, and Engineering teams on requirements and characterization; owning plaque ground truth in partnership with Clinical; curating datasets to improve accuracy; investigating plaque-related complaints and escalations; representing Systems Engineering in design reviews and regulatory submissions; and mentoring Systems Engineers as the team scales.
You bring 10+ years of systems engineering in medical devices and/or regulated imaging, with direct hands-on experience in coronary plaque characterization and atherosclerosis imaging. You have expertise in applied statistics, system design, requirements writing, and establishing measurement accuracy strategies. You demonstrate ownership of system requirements, traceability, and V&V supporting successful regulatory submissions (510(k), De Novo, PMA). You understand design control, quality, risk, and software lifecycle requirements across FDA, EU MDR, and PMDA. Experience developing FDA-regulated Software as a Medical Device (SaMD) is essential. You communicate clearly in writing and verbally, with a track record of authoring Systems Engineering documentation that withstands regulatory scrutiny.
Ideal candidates have experience with quantitative plaque analysis, coronary CT angiography (CCTA), AI/ML-enabled clinical decision support, and familiarity with plaque ground-truth methods (IVUS, OCT, histology). A B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or related discipline is required; Ph.D. preferred. Occasional domestic and international travel required.
