Principal Device Quality Engineer

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. Heartflow is seeking a seasoned Principal Quality Engineer to own the CAPA system and lead as the Subject Matter Expert (SME) and process owner for the process Non-Conformance (NC) and Corrective and Preventive Action (CAPA) subsystems. This is a strategic, high-visibility role is responsible for not only acting as process owner but also executing complex investigations, lead CAPA reviewer and process oversight, and continuous improvement of these critical processes. You will lead cross-functional teams in facilitating CAPA Boards, Root Cause Analysis teams, monitoring KPIs and driving systemic improvements to ensure our products meet the highest standards of safety and efficacy while maintaining process compliance with FDA, ISO, and EU MDR requirements. Job Responsibilities : Process Ownership & Strategy Serve as the Global Process Owner for CAPA subsystem ensuring the actions and records are robust, effective, and compliant. Monitor the health of the CAPA and NC subsystem through the development and analysis of Key Performance Indicators (KPIs) and quality dashboards. Communicate necessary measures to CAPA owners and management. Lead the transition and integration of CAPA processes to meet evolving regulatory focus areas. CAPA & Non-Conformance Management Facilitate and lead the Corrective and Preventive Action (CAPA) Review Board , ensuring robust problem definition, investigation, and effectiveness checks. Deliver training on the CAPA and NC subsystem to ensure procedural requirements and best practices are known throughout the company. Mentor cross-functional owners (R&D, Manufacturing, Supplier Quality) on root cause analysis, investigation best practices to ensure actions are effective and documentation is robust and stands up to regulatory scrutiny. Root Cause Analysis (RCA) & Risk Management Lead complex, high-risk investigations using RCA tools. Partner with QE team to ensure strong linkage between NC/CAPA investigations and the Risk Management File (ISO 14971) , ensuring risk assessments are updated dynamically based on failure modes observed. Audit & Regulatory Support Act as the SME for CAPA and NC during internal audits and external audits (FDA, Notified Body, MDSAP). Perform internal mock audits of the QMS subsystems to identify gaps prior to external inspections. Skills Needed : Regulatory Mastery: Deep working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and EU MDR. Statistical Competence: Proficiency in tools (e.g. Tableau, Minitab) for trending data and verifying effectiveness checks. Strategic Thinking: Ability to look beyond a single non-conformance to identify systemic risks across the processes and organization. Influence without Authority: Proven ability to drive results and enforce quality standards with cross-functional teams (R&D, Clinical, Quality) without direct reporting lines. Technical Writing: Exceptional ability to write clear, concise, and technically accurate investigation summaries that "tell the story" to an auditor. Educational Requirements & Work Experience: Education: Required: Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial) or a related Life Science discipline. Preferred: Master’s degree or Advanced Certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt). Experience: 8+ years of Quality Engineering or QMS related experience in Medical Devices (Class II/III) with CAPA expertise. Demonstrated experience interacting with regulatory bodies (FDA, TUV, BSI, etc.) during inspections. Travel up to 15% A reasonable estimate of the base salary compensation range is $150,858 to $155,000 per year, cash 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. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/ .