Director, Systems Engineering

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 FFR CT 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 (FFR CT 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. The Role As the Director of Systems Engineering, you will lead the RD efforts for system-level design and architecture within our medical device software SDLC. You will be responsible for bridging the gap between unmet clinical needs and engineering execution, ensuring our SaMD products remain compliant, innovative, and patient-centric.. Key Responsibilities Systems Architecture Design: Lead the end-to-end architecture for HeartFlow’s clinical software platform, focusing on new algorithms, reducing turnaround time and expanding clinical insights Human Factors Engineering (HFE): Manage the HFE function to ensure user-centric design is integrated into the SDLC, focusing on safety, usability, and clinical efficacy for medical professionals. Team Leadership: Scale and mentor a cross-functional engineering organization, reinforcing standardized design and review processes. Software SDLC Compliance: Oversee the systems engineering deliverables within a regulated environment, ensuring successful 510(k) clearances and adherence to design controls. Data-Driven Insights: Leverage SQL and Python to synthesize field data and clinical performance metrics to establish root cause and drive data-backed corrective actions. Performance Optimization: Partner with algorithm and software teams to define and track key performance metrics, ensuring high accuracy and reliability across all user needs. Continuous Improvement: Modernize design infrastructure and workflows to improve traceability, quality, and cross-functional alignment across the RD organization. What You Bring Extensive Leadership: 10+ years of experience leading cross-functional teams spanning systems, test, and human factors engineering in regulated medical device environments. Proven Scaling Record: Demonstrated success in growing engineering organizations (e.g., scaling teams from 1 to 10+ engineers). Architecture Expertise: Proven track record of owning end-to-end architecture for complex diagnostic platforms, contributing to successful regulatory clearances. Analytical Power: High proficiency in using data analytics tools to drive root cause analysis and product improvement. Technical Foundation: Strong background in software integration and delivery. Educational Excellence: B.S. in Engineering or equivalent degree A reasonable estimate of the yearly base compensation range is $220,000 to $290,000 , cash bonus, and equity. #LI-Hybrid 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, gen ... (truncated, view full listing at source)