> Markdown version of [/jobs/ext/2103429-staff-systems-engineer-plaque](https://www.wearedevelopers.com/jobs/ext/2103429-staff-systems-engineer-plaque). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Staff Systems Engineer (Plaque) - **Company:** HeartFlow, Inc - **Location:** San Francisco, CA, United States - **Experience:** Expert - **Salary:** $190,000.0 - $250,000.0 - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Artificial Intelligence, Systems Engineering, Dicom, Software Engineering, Software Requirements Analysis, Verification and Validation (Software), Systems Architecture, Fast Healthcare Interoperability Resources, Data Analytics, Health Level Seven International - **Published:** August 18, 2026 - **Apply:** https://www.dice.com/job-detail/9d483729-9941-4334-9b3b-06e69c96d4dd ## About the Role * 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). ## Description * 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. ## Related Videos - [ZEISS & Microsoft - Building the Next Generation Medical Ecosystem in the Cloud](https://www.wearedevelopers.com/videos/424-zeiss-microsoft-building-the-next-generation-medical-ecosystem-in-the-cloud) - [PySpark - Combining Machine Learning & Big Data](https://www.wearedevelopers.com/videos/44-pyspark-combining-machine-learning-big-data) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [How Data is Shaping our Games](https://www.wearedevelopers.com/videos/176-how-data-is-shaping-our-games) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Data Analytics with Microsoft Fabric: End-to-End Use Case with Data Agents](https://www.wearedevelopers.com/videos/1547-data-analytics-with-microsoft-fabric-end-to-end-use-case-with-data-agents) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Dev Digest 129 - Now that's what I call private data!](https://www.wearedevelopers.com/magazine/468-dev-digest-129-now-that-s-what-i-call-private-data) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)