Staff Systems Engineer (CT Imaging)

Heartflow•San Francisco, CA

13h•$190,000 - $250,000

About The Position

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide. As a Staff Systems Engineer with expertise in CT imaging, you will be the technical lead for how Heartflow's products perform across the full CT landscape, from energy-integrating detector CT (EID-CT) to photon-counting CT (PCCT). Reporting to the Sr. Director of Systems Engineering, you will own the system requirements and verification and validation (V&V) strategy for optimizing Heartflow product outputs across scanners, detectors, reconstruction kernels, and imaging techniques, so Heartflow produces accurate, consistent results no matter how or where a scan was acquired. Your work ensures Heartflow converts every CT image, whatever the machine, into a more accurate, earlier diagnoses for our patients. At Heartflow, we are working to transform coronary artery disease from the leading cause of death into a condition that can be managed for life. If you are energized by understanding the nuances of CT acquisition and reconstruction, normalizing image quality across EID-CT and PCCT, and partnering across Algorithm, Software, Clinical, Regulatory, and Quality to bring it to patients, we want to hear from you.

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.

Nice To Haves

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.