Senior Systems Engineer
Core
Define system requirements, functional architecture, and verification strategies for AI-driven non-invasive cardiac analysis software.
Role type
Senior Systems Engineer (Medical Device Software)
Builds
Heartflow FFRCT Analysis, RoadMap Analysis, and Plaque Analysis software for coronary artery disease diagnosis.
Domain
Medical technology / Cardiovascular imaging / AI-driven diagnostics
Deliverable
production ML models
Required skills
Systems engineering fundamentals, functional architecture definition, requirements management, system integration, verification and validation strategy, risk management, technical trade-off analysis, cross-functional leadership, IEC 62304 knowledge, root cause analysis
Preferred skills
FDA-regulated SaMD experience, cardiovascular imaging workflows, Model-Based Systems Engineering (MBSE), ISO 14971/ISO 13485 familiarity, INCOSE certification, cybersecurity guidance for SaMD
Technologies
Jira, Ketryx, Python
Responsibilities
Define system requirements and maintain functional system architecture; ensure traceability between user needs and V&V evidence; identify and resolve complex technical issues across system boundaries; own the system-level V&V strategy; identify, analyze, and mitigate technical and product risks; evaluate and communicate technical trade-offs; lead cross-functional technical efforts from concept to post-market surveillance; promote and improve systems engineering practices across the organization.
Seniority
Senior, hands-on IC with mentorship responsibilities