Staff Systems Engineer (CT Imaging)
About The Position
Heartflow is hiring a Staff Systems Engineer with CT imaging expertise to lead how its products perform across energy-integrating detector CT (EID-CT) and 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 ensure accurate, consistent results regardless of how or where a scan was acquired. The engineer will translate clinical and product goals into testable system requirements, characterize the effect of CT acquisition and reconstruction differences, and work with Engineering and cross-functional partners to address them. The role also represents Systems Engineering in design reviews, program planning, regulatory submissions, and audits, while promoting Systems Engineering practices and mentoring other Systems Engineers. Occasional domestic and international travel is required.
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 technology differences.
- Expertise in applied statistics and designing analyses that quantify imaging performance, variance, and measurement accuracy across 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, HL7/FHIR, and PACS integration.
Responsibilities
- Own the strategy and system architecture for optimizing Heartflow product outputs across EID-CT and PCCT, characterizing differences among scanners, detectors, reconstruction kernels, and imaging techniques and partnering 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 technologies and market changes across OEMs, track new entrants and significant changes, and characterize their impact on Heartflow products while managing the associated proprietary and technical details.
- Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making.
- 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 scales.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
