Senior Plaque Systems Engineer – AI Cardio Imaging

Heartflow; San Francisco (CA); On-site; USD 190,000 - 250,000; Full time

Job summary

Heartflow is seeking a Staff Systems Engineer to lead plaque analysis products, owning requirements, architecture, and V&V strategy. You will define plaque ground truth, curate datasets, and partner with Clinical, Regulatory, and Quality teams to ensure robust validation and compliance.

The role requires 10+ years in medical devices, hands-on plaque characterization, and demonstrated experience with FDA submissions.

Qualifications

• 10+ years of systems engineering in medical devices or regulated imaging.
• Hands-on coronary plaque characterization experience.
• Experience with FDA regulatory submissions (510(k), De Novo, PMA).
• Strong statistical methods for plaque measurement accuracy.
• Excellent written communication and regulatory documentation.

Responsibilities

• Lead Systems Engineering for Heartflow's plaque analysis products, including concept definition, system architecture, interface definition, product integration, and V&V.
• Translate plaque biology and clinical utility into testable requirements with stakeholders.
• Identify and manage system-level risks, design mitigations.
• Collaborate with Clinical, Research, Product, and Engineering to drive requirements.
• Define and own plaque ground truth with Clinical team.
• Curate plaque datasets to improve validation.
• Serve as primary investigator for plaque-related complaints and roadmaps.
• Represent SE in design reviews and regulatory submissions.
• Promote SE best practices and mentor engineers.

Skills

Systems Engineering

Plaque characterization

Statistical analysis

Regulatory submissions

Medical device software

DICOM/HL7/FHIR

Education

B.S./M.S. in SE/EE/BME

Ph.D. preferred

Job description

Heartflow is seeking a Staff Systems Engineer to lead plaque analysis products, owning requirements, architecture, and V&V strategy. You will define plaque ground truth, curate datasets, and partner with Clinical, Regulatory, and Quality teams to ensure robust validation and compliance.

The role requires 10+ years in medical devices, hands-on plaque characterization, and demonstrated experience with FDA submissions.