Staff Systems Engineer (Plaque)

Job 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.

Skills Needed

• 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.

Educational Requirements & Work Experience

• B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline; Ph.D. preferred.
• Occasional domestic and international travel required.

How You Stand Out

• Experience with quantitative plaque analysis, coronary CT angiography (CCTA), and AI/ML-enabled clinical decision support.
• Familiarity with plaque ground-truth and reference-standard methods (e.g., IVUS, OCT, histology).
• Experience applying photon-counting or spectral CT to plaque characterization.
• Expertise in imaging performance and accuracy validation, including relevant statistical methods.
• Expertise in DICOM and medical imaging interoperability standards (e.g., IHE, HL7/FHIR, PACS integration).