Principal Device Quality Engineer

About the role

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 company’s flagship product, the Heartflow FFRCT Analysis, is an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines that 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, helping clinicians identify stenoses (RoadMap™ Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). The company’s pipeline of products is growing, and Heartflow is seeking a Principal Quality Engineer to own the CAPA system and lead as the Subject Matter Expert (SME) and process owner for Non-Conformance (NC) and Corrective and Preventive Action (CAPA) subsystems.

Responsibilities

• Process Ownership & Strategy
  • Serve as the Global Process Owner for the CAPA subsystem, ensuring actions and records are robust, effective, and compliant.
  • Monitor the health of the CAPA and NC subsystems 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 and 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 the 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 observed failure modes.
• Audit & Regulatory Support
  • Act as the SME for CAPA and NC during internal and external audits (FDA, Notified Body, MDSAP).
  • Perform internal mock audits of the QMS subsystems to identify gaps prior to external inspections.

Skills

• 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 processes and the 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.

Qualifications

• 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, TÜV, BSI, etc.) during inspections.

Pay

A reasonable estimate of the base salary compensation range is $150,858 to $155,000 per year, plus cash bonus and equity.