Staff Systems Engineer (CT Imaging)

Heartflow; San Francisco (CA); On-site; USD 200,000 - 250,000; Full time

Job summary

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease. We seek a Staff Systems Engineer with CT imaging expertise to lead system architecture and verification/validation strategy across EID-CT and PCCT, reporting to the Sr. Director of Systems Engineering.

You will own system requirements, ensure traceability, and support regulatory submissions. You will collaborate with cross-functional teams including Algorithm, Software, Clinical,

Qualifications

• 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
• Direct experience with CT acquisition and reconstruction across both EID-CT and PCCT, including image quality and the impact of machine and technological differences.
• Expertise in applied statistics, designing data analyses that quantify imaging performance, variance, and measurement accuracy across key variables such as machines, techniques, and patient populations.
• 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).
• Proficiency in system design, interface definition, requirements writing, and configuration/change control of CT scanners and reconstruction-kernels.
• Experience developing FDA-regulated SaMD.
• Strong written and verbal communication skills; track record of authoring Systems Engineering documentation that withstands regulatory review.

Responsibilities

• Own the strategy and system architecture for optimizing Heartflow product outputs across EID-CT and PCCT (spanning scanners, detectors, reconstruction kernels, and imaging techniques), characterizing how these differences affect Heartflow's products and partnering with Engineering to address them.
• Define the optimal and acceptable ranges of CT scanner and recon settings that result in high quality Heartflow results.
• Partner with cross functional groups on new initiatives (new products, features or improvement in performance) that leverage new CT technologies
• Collaborate with Clinical Research to design data campaigns that quantify imaging performance and variance across machines, techniques, and populations.
• Monitor the CT landscape across OEMs (e.g., Siemens, GE, etc.); track new market entrants and any significant changes that could impact Heartflow products, characterizing how each affects our system and managing the proprietary and technical details required to support the change(s).
• Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making, and serve as the CT subject matter expert in regulatory submissions and audits.
• Define and maintain system requirements with full traceability from user needs through verification, consistent with design controls.
• Translate clinical and product goals into testable, unambiguous requirements in alignment with cross-functional stakeholders.
• Promote Systems Engineering best practices across teams, and mentor Systems Engineers as the team scales.

Skills

Systems Engineering

CT imaging

Statistics

System requirements

Design controls

Software lifecycle

SaMD

Communication

Education

B.S./M.S. in relevant field

Tools

DICOM

PACS integration

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 750,000 patients worldwide.

As a Staff Systems Engineer with expertise in CT imaging, you will be the technical lead for how Heartflow's products perform across the full CT landscape, from energy-integrating detector CT (EID-CT) to photon-counting CT (PCCT). Reporting to the Sr. Director of Systems Engineering, you will own the system requirements and verification and validation (V&V) strategy for optimizing Heartflow product outputs across scanners, detectors, reconstruction kernels, and imaging techniques, so Heartflow produces accurate, consistent results no matter how or where a scan was acquired. Your work ensures Heartflow converts every CT image, whatever the machine, into a more accurate, earlier diagnoses for our patients.

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 understanding the nuances of CT acquisition and reconstruction, normalizing image quality across EID-CT and PCCT, and partnering across Algorithm, Software, Clinical, Regulatory, and Quality to bring it to patients, we want to hear from you.

Job Responsibilities

• Own the strategy and system architecture for optimizing Heartflow product outputs across EID-CT and PCCT (spanning scanners, detectors, reconstruction kernels, and imaging techniques), characterizing how these differences affect Heartflow's products and partnering with Engineering to address them.
• Define the optimal and acceptable ranges of CT scanner and recon settings that result in high quality Heartflow results.
• Partner with cross functional groups on new initiatives (new products, features or improvement in performance) that leverage new CT technologies
• Collaborate with Clinical Research to design data campaigns that quantify imaging performance and variance across machines, techniques, and populations.
• Monitor the CT landscape across OEMs (e.g., Siemens, GE, etc.); track new market entrants and any significant changes that could impact Heartflow products, characterizing how each affects our system and managing the proprietary and technical details required to support the change(s).
• Represent Systems Engineering in design reviews, program planning, and cross-functional decision-making, and serve as the CT subject matter expert in regulatory submissions and audits.
• Define and maintain system requirements with full traceability from user needs through verification, consistent with design controls.
• Translate clinical and product goals into testable, unambiguous requirements in alignment with cross-functional stakeholders.
• 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 experience with CT acquisition and reconstruction across both EID-CT and PCCT, including image quality and the impact of machine and technological differences.
• Expertise in applied statistics, designing data analyses that quantify imaging performance, variance, and measurement accuracy across key variables such as machines, techniques, and patient populations.
• 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).
• Proficiency in system design, interface definition, requirements writing, and configuration/change control of CT scanners and reconstruction-kernels.
• 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

• Deep familiarity with CT scanner platforms and vendor roadmaps; established relationships with CT OEMs a plus.
• Experience with coronary CT angiography (CCTA), non-contrast CT (NCCT), coronary imaging workflows, and AI/ML-enabled clinical decision support.
• 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 $200,000 to $250,000, bonus, and equity.

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.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.