Senior Device Quality Engineer (Medical Devices)

Location: Hybrid role in the San Francisco Bay Area, California, United States

Base salary: $160,000–$180,000 per year, plus bonus.

Company

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

What you will do

• Lead the end-to-end software design control process within the Software Development Lifecycle.
• Apply IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, and cybersecurity standards to development activities.
• Implement validation frameworks for AI/ML, SaaS cloud infrastructure, and cybersecurity within the Quality Management System.
• Conduct design reviews, hazard analyses, fault tree analyses, and software FMEAs.
• Lead software verification and validation by developing test strategies, protocols, and reports.
• Manage the Design History File and support internal and external FDA, Notified Body, and MDSAP audits.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field.
• 5–8 years of experience in quality engineering or product development within the medical device industry.
• Strong critical thinking, attention to detail, communication, documentation, and time management skills.
• Ability to work independently in a fast-paced, adaptive environment.
• Experience supporting technical files and global regulatory submissions, including FDA 510(k)/De Novo, PMDA, and EU-MDR.

Nice to have

• ASQ Certified Quality Engineer, Certified Software Quality Engineer, or Green Belt certification.

Culture & Benefits

• Hybrid work environment in the San Francisco Bay Area.
• Work on AI-enabled cardiac care products used by patients worldwide.
• Collaborate with Engineering, Product, Regulatory Affairs, and R&D teams.
• Equal opportunity workplace committed to an inclusive and respectful environment.
• Base salary plus bonus compensation.