Director, Quality Engineering

HeartFlow, Inc. 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 VC-backed, pre-IPO company 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 250,000 patients worldwide.  

The Director, Quality Engineering will lead and champion a culture of quality. This position is a hands-on role, responsible for leading and implementing the strategy and definition of our system verification and validation standards and criteria including human factors and usability. The candidate will also be responsible for ensuring compliance for our Software as a Medical Device (SaMD) product, specifically related to Design Control V&V. This role will manage the execution of a fast-paced lean validation methodology. Must have a strong familiarity with 21 CFR 820 and ISO 13485 and CSV. #LI-Remote; #LI-IB1

 Job Responsibilities:

• Optimize and clarify HeartFlow system architecture standards to guide consistent planning and execution of verification and validation testing
• Lead cross-functional assessment of existing system-level product requirements & trace matrix, identifying opportunities for improvement and clearly communicating recommendations to core teams and leadership.
• Lead the development of system-level V&V protocols and reports for both new technologies and iterations.
• Lead development of system-level design risk analysis (DFMEA) for new products and iterations.
• Represent HeartFlow as a Design Control subject matter expert in both internal and external audits (MDSAP, FDA, etc).
• Serve as the Quality Engineering lead on business-critical cross-functional programs and actively contribute in setting the strategic direction of each program.
• Support execution of monitoring programs to meet compliance and organizational efficiency goals and to ensure software compliance-related risks are managed to the appropriate level of acceptable residual risk
• Coach and mentor junior team members with some direct report responsibilities
• Actively pursue opportunities for improvement in practices, policies, and procedures and prioritize based on current regulatory environment, guides, and regulations.

Skills Needed:

• Direct operational experience implementing SaMD Design Verification and Validation processes
• Experience with software as a medical device is required. Ideal candidate has experience with AI/ML-based software as a medical device.
• Expertise in evaluating and selecting design validation methodologies and supporting statistical justification when applicable
• Experience with defining product and process validation protocols, including processes with human involvement
• Experience with software verification and validation (tools and methodologies and statistics) in the context of medical devices for FDA and international submissions
• Experience with software change control, release, risk assessment/analysis, defect investigations, and regulatory reporting requirements both pre- and post-market
• Ability to attract and address cross-functional input that drives strategy
• Demonstrated innovation, flexibility, open-mindedness, and adaptability in compliant approach to meet objectives
• Strong experience leading cross-functional programs and ability to manage multiple, simultaneous projects in Quality Engineering
• Demonstrated flexibility, communication, organization skills, time-management and interpersonal skills, with high attention to detail and experience handling multiple projects/tasks simultaneously while meeting deadlines

Educational Requirements & Work Experience: 

• Bachelor’s degree required, Master’s degree preferred (Computer Science, Engineering, or other technical disciplines)
• At least 10 years’ experience in increasingly