Senior Software Quality Engineer - Medical Devices & AI

Meet Life Sciences Ltd.; San Francisco (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. seeks a Senior Software Quality Engineer to drive quality across the product lifecycle in a fast-growing, early-stage environment. You will collaborate with software, systems, and hardware teams to ensure robust quality processes and regulatory readiness.

The role focuses on design quality, DHF governance, risk management and CAPA execution, with ownership of QMS activities and improving software verification and validation practices.

Qualifications

• Bachelor's or Master's in a relevant technical field.
• 8+ years in quality engineering or medical-device development.
• Experience in regulated medical-device environments.
• Strong knowledge of FDA requirements and ISO/IEC standards (13485, 62304, 14971).
• Hands-on V&V, traceability and design controls.
• Experience with AI/ML-enabled SaMD is a plus.

Responsibilities

• Support QMS implementation aligned with FDA QMSR and ISO standards.
• Develop and maintain Design History Files (DHF) with software requirements, traceability and validation documentation.
• Lead risk-management activities (FMEA, hazard analysis) per ISO 14971.
• Oversee software verification and validation activities across the product lifecycle.
• Lead computerized system assurance and validation for software tools.
• Collaborate with suppliers on design transfer and supplier quality.
• Support audits and CAPA processes; drive continuous improvement.
• Promote a quality-first culture across engineering and business teams.

Skills

Regulatory compliance

Risk management

V&V testing

Cross-functional collaboration

Problem solving

Audit readiness

CAPA handling

Education

Bachelor's or Master's degree in Biomedical Engineering, Computer Science, Electrical Engineering or related

Tools

eQMS

FMEA tools

Cybersecurity documentation tools

Job description

Meet Life Sciences Ltd. seeks a Senior Software Quality Engineer to drive quality across the product lifecycle in a fast-growing, early-stage environment. You will collaborate with software, systems, and hardware teams to ensure robust quality processes and regulatory readiness.

The role focuses on design quality, DHF governance, risk management and CAPA execution, with ownership of QMS activities and improving software verification and validation practices.