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Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.
Location: San Francisco, CA (4+ days in office)
Job DescriptionAs a Senior Systems Engineer, you are responsible for the completeness and quality of the system-level design and documentation for Heartflow's core products. You will translate user needs and product requirements into feasible technical requirements, own the functional architecture, and work with members of the R&D team to ensure a traceable, testable, and sustainable design.
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 clinical and business needs into rigorous, testable requirements, developing a high-quality software development process that captures all system-level dependencies, and partnering across Engineering, Product, Clinical, Regulatory, and Quality to improve the lives of our patients, we want to hear from you.
Key Responsibilities- System Architecture & Requirements: Define system requirements and maintain the functional system architecture: the major subsystems, what each must do, and the interfaces and data flows between them.
- Traceability: Ensure traceability between user needs, requirements, and their verification and validation (V&V) evidence, and maintain it as the system evolves.
- System Integration: Identify and resolve complex technical issues across system boundaries, and coordinate dependencies across engineering disciplines.
- Verification & Validation Strategy: Own the system-level V&V strategy: what must be verified or validated, at what level, and what evidence verifies each requirement. Partner with the System Test and Software Engineering teams to ensure requirements are clear and testable.
- Risk Management & Reliability: Identify, analyze, and mitigate technical and product risks. Support failure investigations (e.g., CAPAs, NCs), root cause analysis, corrective actions, and assessments of system reliability and performance.
- Technical Trade-offs: Evaluate and communicate trade-offs involving performance, safety, usability, reliability, scalability, maintainability, schedule, and cost. Use data and engineering judgment to recommend solutions and drive decisions.
- Cross-Functional Technical Leadership: Serve as the technical lead and coordinate cross-functional technical efforts across software, algorithm, quality, regulatory, clinical, product, and operations teams, from concept development through software release and post-market surveillance.
- Systems Engineering Practices: Promote and improve systems engineering practices across the organization, including effective requirements management, risk management, verification planning, traceability, and SDLC improvements. Mentor Systems Engineers as the team scales.
- Education: Bachelor's, Master's, or Ph.D. degree in Systems Engineering, Computer Science, Biomedical Engineering, or a related field.
- Experience: 8+ years of industry experience in systems engineering or a related engineering role developing complex software-enabled products.
- Systems Engineering Fundamentals: Demonstrated experience defining functional system architectures, requirements, specifications, and interfaces.
- Integration & Troubleshooting: Proven ability to integrate multidisciplinary systems, analyze complex technical problems, perform root cause analysis, and drive issues to resolution.
- Verification & Risk: Experience defining system-level verification strategies and reviewing test plans and results for requirement coverage, with a working understanding of product risk management and design controls.
- Software Lifecycle Standards: Working knowledge of IEC 62304 and how it governs the medical device software lifecycle, including software safety classification and lifecycle documentation.
- Technical Judgment: Ability to make and communicate sound technical recommendations by balancing user needs, safety, performance, reliability, quality, schedule, and cost.
- Cross-Functional Leadership: Ability to lead technical discussions, influence decisions, and collaborate effectively across software, algorithms, quality, regulatory, clinical, product, and operations teams.
- Technical Communication: Strong written and verbal communication skills, including the ability to communicate complex technical concepts clearly to both technical and non-technical audiences.
- Technical Tools: Experience with requirements management, issue tracking, documentation, or product lifecycle management tools (e.g., Jira, Ketryx). Familiarity with Python or similar tools for analysis and automation is a plus.
- Experience developing FDA-regulated SaMD or medical imaging systems, including contributing to regulatory submissions.
- Experience with cardiovascular imaging, CT, CCTA, or clinical software workflows.
- Experience with Model-Based Systems Engineering (MBSE), system modeling, or formal architecture methods.
- Familiarity with ISO 14971, ISO 13485, or comparable risk and quality management standards.
- INCOSE certification (ASEP, CSEP) or demonstrated fluency with INCOSE requirements-writing practices.
- Familiarity with FDA premarket cybersecurity guidance and secure product development practices (e.g., SBOM, threat modeling) for connected SaMD.
A reasonable estimate of the base salary compensation range is $180,000 to $215,000, bonus, and equity. #LI-IB1
Skills Required
- Bachelor's, Master's, or Ph.D. degree in Systems Engineering, Computer Science, Biomedical Engineering, or a related field
- 8+ years of industry experience in systems engineering or a related engineering role developing complex software-enabled products
- Experience defining functional system architectures, requirements, specifications, and interfaces
- Experience integrating multidisciplinary systems, analyzing complex technical problems, performing root cause analysis, and driving issues to resolution
- Experience defining system-level verification strategies and reviewing test plans and results for requirement coverage
- Working understanding of product risk management and design controls
- Working knowledge of IEC 62304 and the medical device software lifecycle, including software safety classification and lifecycle documentation
- Ability to make and communicate technical recommendations balancing user needs, safety, performance, reliability, quality, schedule, and cost
- Ability to lead technical discussions, influence decisions, and collaborate across software, algorithms, quality, regulatory, clinical, product, and operations teams
- Strong written and verbal communication skills
- Experience with requirements management, issue tracking, documentation, or product lifecycle management tools
- Experience developing FDA-regulated SaMD or medical imaging systems, including contributing to regulatory submissions
- Experience with cardiovascular imaging, CT, CCTA, or clinical software workflows
- Experience with MBSE, system modeling, or formal architecture methods
- Familiarity with ISO 14971, ISO 13485, or comparable risk and quality management standards
- INCOSE certification or demonstrated fluency with INCOSE requirements-writing practices
- Familiarity with FDA premarket cybersecurity guidance and secure product development practices, including SBOM and threat modeling
- Familiarity with Python or similar tools for analysis and automation
What We Do
Heartflow is the global leader in AI-driven coronary artery disease (CAD) management, transforming how CAD — the world’s leading cause of death — is diagnosed and treated. Our advanced technology generates personalized, precision 3D heart models from a single CT scan, providing clinicians with the clarity and confidence to deliver earlier, more effective treatments — transforming CAD into a disease that can be managed for life. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. With over 400,000 patients treated, more than 1,400 leading institutions adopting our solution, and 99.5% of U.S. lives covered — Heartflow is redefining the standard of coronary care. We're a global company, with employees across the United States, Europe and Japan. Our headquarters are in Mountain View, California, with additional offices in California, Texas, the UK, and Japan. We believe CAD shouldn’t be a silent threat. By making it screenable, diagnosable, and manageable, we’re changing the story of CAD, empowering clinicians to save lives and giving patients more time for what matters most.
Why Work With Us
Join Us to Rewrite the Story of CAD.
