Staff Systems Engineer, Plaque Analysis – Medical Imaging

Socket.dev; 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. You will own requirements, architecture, and V&V strategies for how HeartFlow detects and quantifies coronary plaque.

You will collaborate with Clinical, Regulatory, and Engineering teams to ensure ground-truth validation, regulatory readiness, and robust data-driven analyses across diverse patient populations and imaging modalities.

Qualifications

• 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
• Hands-on experience with coronary plaque characterization and atherosclerosis imaging.
• Expertise in applied statistics and designing data analyses to quantify plaque measurement accuracy.
• Proficiency in system design, interfaces, requirements writing, and ground-truth strategies.
• Experience owning system requirements, traceability, and verification/validation for regulatory submissions (510(k), De Novo, PMA).
• Knowledge of medical device software lifecycle, design controls, quality, and risk in major markets (FDA, EU MDR, PMDA).
• Experience with FDA-regulated SaMD and regulatory audits.

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, unambiguous requirements with cross-functional stakeholders.
• Identify and manage system-level risks using data-driven methods and design mitigations.
• Collaborate with Clinical, Research, Product, and Engineering teams to drive requirements and characterization.
• Define and own the plaque ground truth in collaboration with Clinical teams.
• Curate plaque datasets to improve accuracy and validation.
• Act as the plaque SME in design reviews, regulatory submissions, and audits.
• Mentor and scale the Systems Engineering team.

Skills

Systems engineering

Plaque characterization

Statistics & data analyses

Requirements writing

Regulatory submissions

Education

B.S./M.S. in Systems Eng. or related

Ph.D. preferred

Tools

DICOM

PACS

HL7/FHIR

Job description

HeartFlow is seeking a Staff Systems Engineer to lead plaque analysis products. You will own requirements, architecture, and V&V strategies for how HeartFlow detects and quantifies coronary plaque.

You will collaborate with Clinical, Regulatory, and Engineering teams to ensure ground-truth validation, regulatory readiness, and robust data-driven analyses across diverse patient populations and imaging modalities.