Senior Systems Engineer, Medical AI SaMD – Lead Architecture

HeartFlow, Inc.; San Francisco (CA); On-site; USD 180,000 - 215,000; Full time

Job summary

Heartflow seeks a Senior Systems Engineer to own system-level design and documentation for core products. Translate user needs into technical requirements, manage architecture, and ensure traceability with R&D collaboration.

You will lead cross-functional efforts across software, algorithms, quality, regulatory, clinical, and product teams, driving V&V strategies and risk management for reliable cardiovascular software systems.

Qualifications

• Education in Systems Engineering, Computer Science, Biomedical Engineering, or related field.
• 8+ years in systems engineering or similar for complex software-enabled products.
• Experience defining functional architectures, requirements, specs, interfaces.
• Experience integrating multidisciplinary systems and root-cause analysis.
• Ability to define system-level verification strategies and risk management.
• Knowledge of IEC 62304 and medical device software lifecycle.
• Strong technical judgment balancing user needs, safety, quality and cost.
• Ability to lead cross-functional technical discussions and collaborations.
• Strong written and verbal communication; familiarity with lifecycle tools.

Responsibilities

• Define system requirements and maintain functional architecture across major subsystems.
• Ensure traceability from user needs to verification and validation evidence.
• Coordinate cross-disciplinary system integration and resolve complex issues.
• Own system-level V&V strategy and ensure testability of requirements.
• Identify, analyze, and mitigate technical and product risks; support CAPAs.
• Evaluate trade-offs on performance, safety, reliability, and cost.
• Lead cross-functional technical efforts from concept to release and post-market.
• Promote systems engineering practices and mentor team members.

Skills

System architecture

Traceability

System integration

V&V strategy

Risk management

Technical trade-offs

Cross-functional leadership

Systems engineering practices

Technical judgment

Technical communication

Education

Bachelor's/Master's/Ph.D. in Systems Engineering, CS, or Biomedical Engineering

Tools

Jira

Ketryx

Python

Job description

Heartflow seeks a Senior Systems Engineer to own system-level design and documentation for core products. Translate user needs into technical requirements, manage architecture, and ensure traceability with R&D collaboration.

You will lead cross-functional efforts across software, algorithms, quality, regulatory, clinical, and product teams, driving V&V strategies and risk management for reliable cardiovascular software systems.