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About the Role

Serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives. Shape quality engineering practices organization-wide, bridging the gap between rapid Agile development and rigorous medical device regulations, ensuring that digital health solutions are safe, secure, and compliant.

Responsibilities

• Lead the application and interpretation of global regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45) to daily development activities.
• Monitor regulatory landscape changes and proactively update internal practices.
• Architect and own validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
• Define framework strategy and scalability roadmap across the QMS.
• Define and champion “Compliance at Speed” frameworks across engineering teams.
• Develop scalable playbooks and mentor senior engineers on quality-by-design practices.
• Drive continuous improvement of the QMS, identifying systemic gaps and leading cross-functional initiatives.
• Partner with Quality leadership to influence product strategy, roadmap prioritization, and resource planning.
• Lead and govern software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles.
• Establish review criteria and approve outputs for design reviews.
• Own and govern comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
• Establish risk management methodology and ensure alignment across all product lines.
• Define and own the organization-wide Software Verification and Validation (V&V) strategy.
• Develop and govern test strategies, protocols, and reports for product performance, including for novel AI/ML and SaMD modalities.
• Define standards for and govern the Design History File (DHF) from concept to commercialization.
• Lead and coordinate the organization during internal and external audits as a primary subject matter expert for software processes.
• Develop audit readiness programs and host regulatory agency interactions.
• Author, review, and approve technical files for global submissions (FDA, PMDA, EU-MDR).
• Serve as the quality sign-off authority for regulatory submissions.
• Provide technical coaching and quality training to R&D and Product teams.
• Mentor and develop Senior and mid-level Quality Engineers.
• Contribute to hiring and capability planning.
• Represent Heartflow’s quality and compliance perspective in industry forums, working groups, and external partnerships.

Requirements

• Strong critical thinking skills and great attention to detail.
• Ability to work as a self-starter in a fast-paced, adaptive environment.
• Demonstrated ability to influence without authority and drive alignment across engineering, regulatory, and product leadership.

Skills

• Excellent communication skills
• Excellent documentation skills
• Excellent time management skills
• Deep expertise in quality systems strategy
• QMS architecture
• CAPA program design for SaMD organizations

Location

• Remote
• Hybrid

Work Type

• Full-time

Experience Level

• 10+ years of experience in quality engineering or product development within the medical device industry
• At least 3 years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products

Education Level

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
• Master’s degree in a relevant technical or quality discipline preferred
• ASQ Certified Quality Engineer (CQE) preferred
• Certified Software Quality Engineer (CSQE) preferred
• Black Belt preferred

Salary/Compensations

• $165,000 - $205,000

Benefits

• Bonus
• Equity

About the Company

• Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology.
• The flagship product is an AI-driven, non-invasive cardiac test called the Heartflow FFRCT Analysis.
• Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway.
• Heartflow is a publicly traded company (HTFL).
• Heartflow has received international recognition for exceptional strides in healthcare innovation.
• Heartflow is supported by medical societies around the world.
• Heartflow has product clearance for use in the US, UK, Europe, Japan and Canada.
• Heartflow products have been used for more than 500,000 patients worldwide.

Equal Opportunity

• 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.