Senior Quality Engineer - Software/Firmware

Senior Quality Engineer - Software/Firmware at Intuitive Surgical in Sunnyvale, CA

A senior quality engineer supports the entire product development lifecycle from concept through commercialization and acts as a core member of the cross-functional software development team. The role provides expert guidance on software development lifecycle, design controls, risk management, anomaly tracking, and code reviews to ensure the reliability, safety, and regulatory compliance of software used in medical devices.

Responsibilities

• Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
• Participate in design reviews, code reviews, defect tracking, software validation activities, and ensure adherence to SDLC processes, including Agile methodologies.
• Support risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1; collaborate with R&D and testing teams to identify and mitigate software defects.
• Ensure completeness and full coverage of software verification and validation (V&V) protocols, including unit, integration, and system testing.
• Contribute to the development of the product design history file and ensure compliance with internal processes and external standards and regulations.
• Define design inputs, design outputs, and traceability matrices in partnership with engineering.
• Support Regulatory Affairs with submissions and responding to submission questions; assist with internal and external audits and interaction with auditors.
• Drive continuous improvement in software quality processes and methodologies; implement test automation strategies to improve efficiency and coverage.
• Collaborate with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery.

Requirements

• Required Skills and Experience

• Experience with medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.

• Experience with risk-based software validation, software test automation, and SDLC processes.

• Expertise in data modeling and interpretation (e.g., field product performance, log analysis, reliability modeling).

• Ability to navigate quality systems with minimal oversight on individual projects and to make balanced risk-based decisions to drive product quality.

• Strong problem-solving abilities with minimal supervision and the capacity to convey complex information to teams and executive management.

• Required Education and Training

• A minimum of 8 years of related experience with a university degree in computer science, software/biomedical/systems/electrical/mechanical engineering, math, or physics, or 5 years of relevant experience with an advanced degree in the same disciplines.

• At least 2 years in a regulated industry is preferred.

• Preferred Skills and Experience

• Experience with AI/ML-based medical software (SaMD/embedded AI).

• Knowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA).