As a Staff Systems Engineer with expertise in plaque, you will be the technical lead for Heartflow's plaque analysis products. Reporting to the Sr. Director of Systems Engineering, you will own the system requirements, architecture, and verification and validation (V&V) strategy for how Heartflow detects, characterizes, and quantifies coronary plaque. You will set the standard for plaque measurement accuracy and the ground truth we validate against. Plaque is where coronary artery disease begins, and your work will define how the future of this disease is caught and managed.
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 turning plaque biology and clinical needs into rigorous, testable requirements, defining what "accurate" means, and partnering across Algorithm, Software, Clinical, Regulatory, and Quality to improve the lives of our patients, we want to hear from you.
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).
A reasonable estimate of the base salary compensation range is $190,000 to $250,000, bonus, and equity. #LI-IB1
