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Staff Systems Engineer (CT Imaging)

Heartflow· Software Engineering
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San Francisco, CA$190k - $250kFull-timePosted 2mo ago

About the role

Technical lead for how Heartflow's products perform across the full CT landscape, owning system requirements and V&V strategy to optimize product outputs across scanners, detectors, reconstruction kernels, and imaging techniques for CT imaging.

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.

Qualifications

  • 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.

Skills

Required:CT acquisition and reconstruction (EID-CT and PCCT)Applied statistics for imaging performanceRegulatory submissions support (510(k), De Novo, PMA)Design controls and software lifecycle (FDA, EU MDR, PMDA)Systems engineering documentation

Benefits

  • Bonus
  • Equity
Last updated Sep 14, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
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