Location: San Francisco, CA (4+ days in office)

Job Description

As 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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