SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, uses cutting-edge AI to generate 3D models of coronary arteries, helping clinicians identify blockages and assess blood flow impact. The product is cleared in the US, UK, Europe, Japan, and Canada, and has been used for over 500,000 patients worldwide.
As Staff Systems Engineer for CT Imaging, you will be the technical lead ensuring HeartFlow's products perform optimally across the entire CT landscape—from energy-integrating detector CT (EID-CT) to photon-counting CT (PCCT). Reporting to the Sr. Director of Systems Engineering, you own system requirements, verification and validation (V&V) strategy, and optimization of HeartFlow outputs across different scanners, detectors, reconstruction kernels, and imaging techniques. Your work ensures consistent, accurate results regardless of acquisition method or location.
Key responsibilities include: defining system architecture and strategy for EID-CT and PCCT optimization; establishing optimal and acceptable ranges for CT scanner and reconstruction settings; partnering with cross-functional teams (Algorithm, Software, Clinical, Regulatory, Quality) on new products and features; collaborating with Clinical Research to design data campaigns quantifying imaging performance variance; monitoring the CT OEM landscape (Siemens, GE, etc.) for market changes; representing Systems Engineering in design reviews and regulatory submissions; defining and maintaining system requirements with full traceability; translating clinical and product goals into testable requirements; and mentoring Systems Engineers as the team scales.
Required qualifications: 10+ years Systems Engineering experience in medical devices and/or regulated imaging; direct experience with CT acquisition and reconstruction across EID-CT and PCCT; expertise in applied statistics and data analysis for imaging performance; demonstrated ownership of system requirements, traceability, and V&V supporting regulatory submissions (510(k), De Novo, PMA); working knowledge of design control, quality, risk, and software lifecycle requirements (FDA, EU MDR, PMDA); proficiency in system design, interface definition, requirements writing, and configuration/change control; experience developing FDA-regulated Software as a Medical Device (SaMD); strong written and verbal communication skills with track record of regulatory-grade documentation. Educational background: B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or related discipline; Ph.D. preferred. Occasional domestic and international travel required.
