Heartflow - Staff Systems Engineer (CT Imaging)
Requirements
• 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products. • Direct experience with CT acquisition and reconstruction across both EID-CT and PCCT, including image quality and the impact of machine and technological differences. • Expertise in applied statistics, designing data analyses that quantify imaging performance, variance, and measurement accuracy across key variables such as machines, techniques, and patient populations. • Demonstrated ownership of system requirements, traceability, and verification and validation supporting successful regulatory submissions (e.g., 510(k), De Novo, PMA). • Working knowledge of the design control, quality, risk, and software lifecycle requirements governing medical device software across major markets (FDA, EU MDR, PMDA). • Proficiency in system design, interface definition, requirements writing, and configuration/change control of CT scanners and reconstruction-kernels. • Experience developing FDA-regulated SaMD. • Strong written and verbal communication skills; track record of authoring Systems Engineering documentation that withstands regulatory review. • Educational Requirements & Work Experience • B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline; Ph.D. preferred. • Occasional domestic and international travel required. • How You Stand Out • Deep familiarity with CT scanner platforms and vendor roadmaps; established relationships with CT OEMs a plus. • Experience with coronary CT angiography (CCTA), non-contrast CT (NCCT), coronary imaging workflows, and AI/ML-enabled clinical decision support. • Expertise in DICOM and medical imaging interoperability standards (e.g., IHE, HL7/FHIR, PACS integration).
Responsibilities
• Own the strategy and system architecture for optimizing Heartflow product outputs across EID-CT and PCCT (spanning scanners, detectors, reconstruction kernels, and imaging techniques), characterizing how these differences affect Heartflow's products and partnering with Engineering to address them. • Define the optimal and acceptable ranges of CT scanner and recon settings that result in high quality Heartflow results. • Partner with cross functional groups on new initiatives (new products, features or improvement in performance) that leverage new CT technologies • Collaborate with Clinical Research to design data campaigns that quantify imaging performance and variance across machines, techniques, and populations. • Monitor the CT landscape across OEMs (e.g., Siemens, GE, etc.); track new market entrants and any significant changes that could impact Heartflow products, characterizing how each affects our system and managing the proprietary and technical details required to support the change(s). • Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making, and serve as the CT subject matter expert in regulatory submissions and audits. • Define and maintain system requirements with full traceability from user needs through verification, consistent with design controls. • Translate clinical and product goals into testable, unambiguous requirements in alignment with cross-functional stakeholders. • Promote Systems Engineering best practices across teams, and mentor Systems Engineers as the team scales.
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