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 $188,000 - $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.
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.
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