Senior Software Quality Engineer

Job Summary

We are partnering with a rapidly growing neurotechnology client in San Francisco focused on developing complex neuro devices. They are seeking a Senior Software Quality Engineer to partner cross-functionally with Engineering and Quality teams to ensure products meet high-quality and regulatory standards throughout the development lifecycle. This is a hands-on role supporting software, systems engineering, supplier activities, and QMS implementation.

Primary Responsibilities

• Support implementation of the QMS in compliance with FDA QMSR, ISO 13485, IEC 62304, IEC 62366-1, and related standards.
• Maintain Design History Files (DHFs), including requirements, design specifications, V&V documentation, risk files, cybersecurity records, and traceability matrices.
• Lead risk-management activities such as FMEA and hazard analysis in accordance with ISO 14971.
• Support software validation and computerized system assurance activities.
• Collaborate with suppliers and support design-transfer activities.
• Participate in internal and external audits.
• Support CAPAs, nonconformances, root-cause analysis, and quality-data reviews.
• Promote continuous improvement across Engineering and Quality teams.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.
• 8+ years of quality engineering or medical-device development experience.
• Strong knowledge of FDA, ISO 13485, IEC 62304, ISO 14971, and IEC 62366-1.
• Experience in regulated medical-device environments.
• Hands-on software V&V and design-control experience.
• Strong experience with FMEA, risk analysis, CAPA, and DHF documentation.
• Experience with eQMS tools and strong documentation skills.
• AI/ML experience is a plus.
• Strong communication, critical-thinking, and cross-functional collaboration skills.
• Comfortable working in a fast-paced, early-stage environment.