← All roles

Staff Systems Engineer (Plaque)

Heartflow· Software Engineering
Apply on company site
San Francisco, CA$190k - $250k + equity + bonusfull-timePosted 2mo ago

About the role

Staff Systems Engineer leading Heartflow's plaque analysis products, owning system requirements, architecture, and verification/validation strategy for detection, characterization, and quantification of coronary plaque; partnering across Algorithm, Software, Clinical, Regulatory, and Quality to improve patient outcomes in plaque analysis.

Responsibilities

  • Lead Systems Engineering for Heartflow's plaque analysis products, including concept definition, system architecture, interface definition, product integration, and verification and validation.
  • Translate coronary plaque biology, progression, and clinical utility, together with product goals, into testable, unambiguous requirements in partnership with cross-functional stakeholders.
  • Identify, analyze, and manage system-level technical risks using a data-driven approach, collaborating cross-functionally to design and implement mitigations in the product.
  • Collaborate with cross-functional teams (Clinical, Research, Product, and Engineering) to drive the requirements and characterization activities that extend and improve plaque analysis.
  • Define and own the plaque ground truth, in conjunction with the Clinical team, to ensure plaque products are properly validated.
  • Curate plaque datasets to improve accuracy and validation.
  • Serve as the primary investigator for plaque-related complaints and escalations, diagnosing root cause and translating findings into a roadmap to resolve them.
  • Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making, and serve as the plaque subject matter expert in regulatory submissions and audits.
  • 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, hands-on experience with coronary plaque characterization and atherosclerosis imaging.
  • Expertise in applied statistics, designing data analyses that quantify plaque measurement accuracy and performance across key variables such as patient populations, scanners, and techniques.
  • Proficiency in system design, interface definition, requirements writing, and establishing measurement accuracy and ground-truth strategies.
  • 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).
  • Experience developing FDA-regulated SaMD.
  • Strong written and verbal communication skills; track record of authoring Systems Engineering documentation that withstands regulatory review.

Skills

Required:Systems EngineeringCoronary plaque characterizationApplied statistics for plaque analysisRegulatory submissionsRegulatory knowledge (FDA, EU MDR, PMDA)FDA-regulated SaMDDocumentation and communication
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
Company profileWebsite

More open roles at Heartflow