Staff Systems Engineer (CT Imaging)

Heartflow•San Francisco, CA

1d•$200,000 - $250,000

About The Position

Heartflow is seeking a Staff Systems Engineer with CT imaging expertise to lead how its products perform across the CT landscape, from energy-integrating detector CT (EID-CT) to photon-counting CT (PCCT). Reporting to the Sr. Director of Systems Engineering, this role owns system requirements and the verification and validation (V&V) strategy for optimizing product outputs across scanners, detectors, reconstruction kernels, and imaging techniques. The goal is to deliver accurate, consistent results regardless of where or how a scan was acquired. The engineer will work across Algorithm, Software, Clinical, Regulatory, and Quality teams to understand CT acquisition and reconstruction, normalize image quality across EID-CT and PCCT, and support new CT technologies and product initiatives. The role also contributes technical expertise to regulatory submissions and audits and promotes Systems Engineering practices while mentoring other Systems Engineers. Heartflow is a medical technology company focused on coronary artery disease. Its AI-driven, non-invasive cardiac products support clinicians in identifying coronary stenoses, assessing blood flow, and characterizing coronary atherosclerosis. The company’s products are cleared for use in the US, UK, Europe, Japan, and Canada, and have been used for more than 750,000 patients worldwide. The position requires occasional domestic and international travel. A reasonable estimate of base salary is $200,000 to $250,000, plus bonus and equity.

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 effects of machine and technology differences.
Expertise in applied statistics and designing data analyses to quantify imaging performance, variance, and measurement accuracy across variables such as machines, techniques, and patient populations.
Demonstrated ownership of system requirements, traceability, and verification and validation supporting successful regulatory submissions, such as 510(k), De Novo, or PMA.
Working knowledge of design control, quality, risk, and software lifecycle requirements governing medical device software across major markets, including FDA, EU MDR, and 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 and a track record of authoring Systems Engineering documentation that withstands regulatory review.
B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline.
Occasional domestic and international travel is required.

Nice To Haves

Ph.D. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline.
Deep familiarity with CT scanner platforms and vendor roadmaps.
Established relationships with CT OEMs.
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, such as IHE and HL7/FHIR, and PACS integration.

Responsibilities

Own the strategy and system architecture for optimizing Heartflow product outputs across EID-CT and PCCT, including scanners, detectors, reconstruction kernels, and imaging techniques; characterize effects on products and partner with Engineering to address them.
Define optimal and acceptable ranges of CT scanner and reconstruction settings that produce high-quality Heartflow results.
Partner with cross-functional groups on initiatives involving new products, features, or performance improvements 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 CT OEMs and market developments, assess changes that could affect Heartflow products, and manage the technical and proprietary details needed to support those changes.
Represent Systems Engineering in design reviews, program planning, and cross-functional decisions, and serve as the CT subject matter expert for 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 grows.
Travel domestically and internationally occasionally.