Sr. Manager, Agile Quality System Development

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.  

This position will be key to building the next generation HeartFlow quality management system and will report to the Director, Quality Systems. #LI-Remote; #LI-IB1

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related field, completed by the start date
• Minimum of 5 years of people management experience in a digital health company
• Internal auditor certification and multiple years of agile QMS system auditing experience
• Strong problem-solving skills and the ability to work independently as well as collaboratively in a team environment.

How You Stand Out

• Deep experience with machine learning concepts and frameworks, and the medical device software development (e.g., AAMI TIR45:2003)
• Strong background with previously demonstrated examples for revamping monolithic quality management systems into highly agile and iterative systems to support highly compliant and quality driven software development practices
• Deep knowledge with previously demonstrated examples for breaking down the monolithic quality management systems into multi-tier risk based modular systems to increase delivery speed and software quality
• Direct hands-on experience with software development tools, such as Git and previously demonstrated examples around improving software versioning, configuration management, and traceability via collaboration with engineering’
• Direct experience with previously demonstrated examples for generating modular QMS system documentation and working with various regulatory agencies (e.g. FDA, Notified Bodies, MHRA, Health Canada, PMDA, TGA etc.) to explain the risk-tiered approach while …