Principal Device Quality Engineer

Heartflow; San Francisco (CA); Hybrid; USD 190,000 - 240,000; Full time

Job summary

Heartflow in San Francisco is advancing AI-driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME for software quality and design excellence, aligning Agile development with medical device regulations across the SDLC.

Lead design control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR; mentor R&D, Product, and Program teams; drive compliance at speed in a regulated environment.

Qualifications

• Bachelor’s degree in software/CS/biomedical engineering required; Master’s preferred.
• 10+ years in quality engineering or product development within the medical device industry.
• Certifications (Preferred): CQE, CSQE, or Six Sigma Black Belt.
• Experience with core quality standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485) and regulatory submissions.

Responsibilities

• Provide strategic leadership as SME for global regulatory standards (IEC/ISO, FDA, MDSAP).
• Lead SDLC improvements for AI/ML, cloud, and cybersecurity within QMS.
• Oversee V&V activities; review test plans, protocols, and reports for safety and efficacy.
• Drive DHF management and support regulatory audits and inspections (FDA, Notified Bodies).
• Collaborate on regulatory submissions (FDA, PMDA, EU-MDR) and mentor R&D, Product, and Program teams.

Skills

Critical thinking

Self-starter

Communication and documentation

Time management

Education

Bachelor’s degree in Software Engineering / Computer Science / Biomedical Engineering

Master’s degree preferred

10+ years of quality engineering experience in medical devices

CQE / CSQE / Six Sigma Black Belt preferred

Job description

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 (RoadMapAnalysis), 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 Opportunity

As the Principal Device Quality Engineer, you will serve as the global subject matter expert (SME) for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, and compliant.

Your core responsibility will be overseeing compliance around the end to end design control process within the Heartflow’s Software Development Lifecycle (SDLC), advising on everything from initial architecture and security-by-design to global regulatory submissions and post-market surveillance.

Key Responsibilities

Strategic Leadership

• SME Guidance: Act as the primary authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.
• Modern SDLC Evolution: Lead the integration of modern technologies into the Quality Management System (QMS), specifically defining validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1).
• Agile Transformation: Partner with engineering teams to implement "Compliance at Speed," applying Agile best practices while maintaining total regulatory rigor. Commit to execution to ensure predictable, complete, high quality releases.

Design Quality & Risk Management

• Technical Architecture Review: Advise on software architecture through the lens of safety, security-by-design, and privacy-by-design.
• Advanced Risk Analysis: Support comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (Design and Software), specifically addressing software-driven failure modes.
• V&V Oversight: Technical lead for Software Verification and Validation (V&V); review and approve test strategies, protocols, and reports to ensure robust product performance.

Execution & Compliance

• DHF Management: Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring a seamless design transfer.
• Audit Representation: Represent the organization’s software QMS during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP).

Cross-Functional Collaboration

• Regulatory Submissions: Collaborate with Regulatory Affairs to author technical documentation for global bodies, including FDA, PMDA, and EU-MDR.
• Mentorship: Provide high-level technical guidance and training to R&D, Product and Program.

Skills Needed

• Strong critical thinking skills and great attention to detail
• Ability to work as a self-starter in a fast-paced, adaptive environment
• Excellent communication, documentation, and time management skills

Educational Requirements & Work Experience

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required; a Master’s degree is strongly preferred.
• 10+ years of experience in quality engineering or product development within the medical device industry.
• Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt.

This position has an estimated base salary of $190,000 - $240,000, bonus, and equity. #LI-IB1; #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, 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.