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Salary: USD 180,000 - 215,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) advancing the diagnosis and management of coronary artery disease using AI-driven cardiac imaging analysis. The company's flagship product, HeartFlow FFR_CT Analysis, provides 3D models of coronary arteries to help clinicians assess blood flow and identify stenoses. The product is cleared in the US, UK, Europe, Japan, and Canada, and has been used for over 750,000 patients worldwide.
As a Senior Systems Engineer, you will own the completeness and quality of system-level design and documentation for HeartFlow's core products. You will translate clinical and business needs into rigorous, testable technical requirements, develop and maintain the functional system architecture, and coordinate across R&D, Product, Clinical, Regulatory, and Quality teams.
Key responsibilities include:
• Define and maintain functional system architecture, including major subsystems, interfaces, and data flows
• Establish and maintain traceability between user needs, requirements, and verification/validation evidence as the system evolves
• Identify and resolve complex technical issues across system boundaries and coordinate dependencies across engineering disciplines
• Own the system-level verification and validation strategy, partnering with System Test and Software Engineering teams to ensure requirements are clear and testable
• Identify, analyze, and mitigate technical and product risks; support failure investigations, root cause analysis, and corrective actions
• Evaluate and communicate technical trade-offs involving performance, safety, usability, reliability, scalability, maintainability, schedule, and cost
• Serve as technical lead and coordinate cross-functional efforts from concept development through software release and post-market surveillance
• Promote and improve systems engineering practices across the organization; mentor Systems Engineers as the team scales
The role requires 4+ days in office in San Francisco.
REQUIREMENTS:
Education: Bachelor's, Master's, or Ph.D. in Systems Engineering, Computer Science, Biomedical Engineering, or related field.
Experience: 8+ years in systems engineering or related engineering role developing complex software-enabled products.
Core competencies:
• Demonstrated experience defining functional system architectures, requirements, specifications, and interfaces
• Proven ability to integrate multidisciplinary systems, analyze complex technical problems, perform root cause analysis, and drive issues to resolution
• Experience defining system-level verification strategies and reviewing test plans for requirement coverage
• Working understanding of product risk management and design controls
• Working knowledge of IEC 62304 and medical device software lifecycle governance, including software safety classification and lifecycle documentation
• Ability to make and communicate sound 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 for both technical and non-technical audiences
• 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 Software as a Medical Device (SaMD) or medical imaging systems, including 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
