Senior Quality Engineer (SaMD)

Location: Hybrid in Golden, Colorado; required office presence up to 3 days per week and as needed for department or project meetings, with remote work on other days.

Salary: $95,000–$115,000 per year

Company

hirify.global develops clinically validated AI software for medical imaging, intelligent workflows, and hospital care, supporting more than 2,500 hospitals in over 100 countries.

What you will do

• Establish and maintain software quality engineering processes across the full SDLC for SaMD in alignment with IEC 62304, ISO 13485, and FDA regulations.
• Review requirements, architecture specifications, and user stories for bidirectional traceability, testability, and risk mitigation.
• Lead ISO 14971 product risk analysis, including software hazards, failure modes, and risk controls.
• Review and approve software test plans, automated and manual protocols, V&V reports, and clinical evaluation deliverables.
• Manage defects, anomalies, non-conformances, root cause analysis, corrective actions, and verified closure.
• Partner with R&D, Platform Engineering, Clinical Affairs, and Regulatory while supporting tool validation, audits, and QMS improvements.

Requirements

• 5+ years of software quality engineering experience in medical devices, digital health, or life sciences.
• Bachelor of Science in Biomedical Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related technical field.
• Hands-on expertise with SaMD and IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820/QMSR.
• Experience managing design history files, requirement traceability matrices, risk documentation, and V&V reports for commercial releases.
• Experience managing software defects, CAPA, non-conformances, and rigorous root cause investigations with engineering teams.
• Strong written and verbal communication skills, including the ability to maintain accountability across functions and delivery milestones.
• High attention to detail and ability to work under tight sprint cycles and shifting priorities in a high-growth environment.

Nice to have

• Experience qualifying or testing AI/ML algorithms, computer vision pipelines, or diagnostic decision-support software.
• Familiarity with AWS, cloud-native architectures, CI/CD validation pipelines, and Agile/Scrum.
• Experience with Software Tool Validation under ISO/TR 80002-2, including Jira, GitHub, Propel, or TestRail.
• Experience with FDA 510(k), De Novo, or EU MDR submissions and external regulatory audits.
• ASQ Certified Software Quality Engineer or Certified Quality Engineer certification.

Culture & Benefits

• Hybrid work arrangement with remote flexibility when office presence is not required.
• Agile, AI-first environment balancing rapid product iteration with regulatory rigor.
• Cross-functional collaboration across Engineering, Clinical, Product, Platform Engineering, and Regulatory teams.
• Inclusive workplace with equal employment opportunities and protection from discrimination and harassment.