Staff Systems Engineer (CT Imaging)

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

Job summary

Heartflow in San Francisco seeks a Staff Systems Engineer specializing in CT imaging to lead system requirements, verification and validation across EID-CT and PCCT. You will partner with Engineering to ensure accurate, consistent results from CT scans across different machines.

Reporting to the Sr. Director of Systems Engineering, you will influence design reviews and regulatory submissions (510(k), De Novo, PMA) and guide cross-functional teams while maintaining traceability and design

Qualifications

• 10+ years of Systems Engineering experience in medical devices or regulated imaging products.
• Direct experience with CT acquisition and reconstruction across EID-CT and PCCT.
• Expertise in statistics and data analyses to quantify imaging performance across variables.
• Ownership of system requirements, traceability, and V&V for regulatory submissions (510(k), De Novo, PMA).
• Familiarity with design controls, quality, risk and software lifecycle in major markets (FDA, EU MDR, PMDA).
• Proficient in written and verbal communication; experience authoring SE documentation for regulatory review.

Responsibilities

• Own the strategy and architecture for optimizing Heartflow CT outputs across scanners and technologies.
• Define CT settings ranges that yield high-quality Heartflow results.
• Collaborate with cross-functional teams on new initiatives leveraging CT tech.
• Design data campaigns with Clinical Research to quantify imaging performance and variance.
• Monitor CT landscape across OEMs and assess impact on Heartflow products.
• Represent Systems Engineering in design reviews and regulatory submissions.
• Maintain full traceability of system requirements from user needs through verification.
• Translate clinical goals into testable, unambiguous requirements.

Skills

Systems Engineering

CT imaging expertise

Statistical analysis

Regulatory submissions

FDA/EU MDR/PMDA knowledge

SaMD development

Cross-functional leadership

Documentation/writing

Education

BS/MS in Systems Engineering / Biomedical Engineering / Physics

Ph.D. preferred

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 (RoadMap™Analysis), 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 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 $190,000 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.