Staff Systems Engineer (Plaque)

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 a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting‑edge technology. The flagship product—an AI-driven, non‑invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color‑coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI‑driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.

As a Staff Systems Engineer with expertise in plaque, you will be the technical lead for Heartflow's plaque analysis products. Reporting to the Sr. Director of Systems Engineering, you will own the system requirements, architecture, and verification and validation (V&V) strategy for how Heartflow detects, characterizes, and quantifies coronary plaque. You will set the standard for plaque measurement accuracy and the ground truth we validate against. Plaque is where coronary artery disease begins, and your work will define how the future of this disease is caught and managed.

At Heartflow, we are working to transform coronary artery disease from the leading cause of death into a condition that can be managed for life. If you are energized by turning plaque biology and clinical needs into rigorous, testable requirements, defining what "accurate" means, and partnering across Algorithm, Software, Clinical, Regulatory, and Quality to improve the lives of our patients, we want to hear from you.

Job Responsibilities

• Lead Systems Engineering for Heartflow's plaque analysis products, including concept definition, system architecture, interface definition, product integration, and verification and validation.
• Translate coronary plaque biology, progression, and clinical utility, together with product goals, into testable, unambiguous requirements in partnership with cross-functional stakeholders.
• Identify, analyze, and manage system-level technical risks using a data-driven approach, collaborating cross-functionally to design and implement mitigations in the product.
• Collaborate with cross-functional teams (Clinical, Research, Product, and Engineering) to drive the requirements and characterization activities that extend and improve plaque analysis.
• Define and own the plaque ground truth, in conjunction with the Clinical team, to ensure plaque products are properly validated.
• Curate plaque datasets to improve accuracy and validation.
• Serve as the primary investigator for plaque-related complaints and escalations, diagnosing root cause and translating findings into a roadmap to resolve them.
• Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making, and serve as the plaque subject matter expert in regulatory submissions and audits.
• Promote Systems Engineering best practices across teams, and mentor Systems Engineers as the team scales.

Skills Needed

• 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
• Direct, hands‑on experience with coronary plaque characterization and atherosclerosis imaging.
• Expertise in applied statistics, designing data analyses that quantify plaque measurement accuracy and performance across key variables such as patient populations, scanners, and techniques.
• Proficiency in system design, interface definition, requirements writing, and establishing measurement accuracy and ground‑truth strategies.
• Demonstrated ownership of system requirements, traceability, and verification and validation supporting successful regulatory submissions (e.g., 510(k), De Novo, PMA).
• Working knowledge of the design control, quality, risk, and software lifecycle requirements governing medical device software across major markets (FDA, EU MDR, PMDA).
• Experience developing FDA‑regulated SaMD.
• Strong written and verbal communication skills; track record of authoring Systems Engineering documentation that withstands regulatory review.

Educational Requirements & Work Experience

• B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline; Ph.D. preferred.
• Occasional domestic and international travel required.

How You Stand Out

• Experience with quantitative plaque analysis, coronary CT angiography (CCTA), and AI/ML-enabled clinical decision support.
• Familiarity with plaque ground-truth and reference‑standard methods (e.g., IVUS, OCT, histology).
• Experience applying photon‑counting or spectral CT to plaque characterization.
• Expertise in imaging performance and accuracy validation, including relevant statistical methods.
• Expertise in DICOM and medical imaging interoperability standards (e.g., IHE, HL7/FHIR, PACS integration).

A reasonable estimate of the base salary compensation range is $190,000 to $250,000, bonus, and equity. #LI-IB1

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.