Principal Device Quality Engineer (AI/ML)

Location: Hybrid, San Francisco Bay Area, California, United States

Base salary: $190,000–$240,000 per year, plus bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive cardiac solutions for diagnosing and managing coronary artery disease.

What you will do

• Serve as the software quality and design excellence subject matter expert for SaMD and AI/ML-enabled products.
• Oversee end-to-end design controls within the software development lifecycle from concept through commercialization and design transfer.
• Define validation frameworks for AI/ML, SaaS cloud infrastructure, and cybersecurity within the quality management system.
• Review software architecture for safety-by-design, security-by-design, and privacy-by-design considerations.
• Lead hazard analysis, fault tree analysis, FMEAs, and software verification and validation activities.
• Represent the software QMS in audits and support technical documentation for FDA, PMDA, EU-MDR, and other global submissions.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field.
• 10+ years of experience in quality engineering or product development within the medical device industry.
• Expertise in IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, and ISO 81001-5-1.
• Experience with software architecture reviews, design controls, risk management, and software V&V.
• Strong critical thinking, attention to detail, communication, documentation, and time management skills.
• Ability to work independently in a fast-paced, adaptive environment.

Nice to have

• Master’s degree in a relevant technical field.
• ASQ Certified Quality Engineer, Certified Software Quality Engineer, or Six Sigma Black Belt certification.

Culture & Benefits

• Hybrid work environment.
• Opportunity to contribute to precision heartcare and medical technology innovation.
• Bonus and equity in addition to base salary.
• Collaborative work with Engineering, Regulatory Affairs, Product, and Program teams.