Senior Quality Engineer — Medical Device Software & Firmware

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Senior Quality Engineer to support the full software lifecycle for medical devices, from concept to commercialization. You will guide compliance with ISO and FDA standards, participate in design reviews, and ensure robust software verification and validation.

The role requires experience in regulatory quality systems, risk management, and cross-functional collaboration with R&D, manufacturing, and regulatory affairs to deliver safe, high-impact

Qualifications

• Experience with medical device standards and regulatory frameworks.
• Proven expertise in SDLC processes and risk-based software validation.
• Ability to lead cross-functional teams and communicate with executives.

Responsibilities

• Software quality assurance & compliance activities to ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
• Lead risk management activities and collaborate with R&D and testing teams.
• Support design history file, design inputs/outputs, and traceability matrices.
• Provide regulatory support with submissions and audits.
• Drive process improvement and test automation strategies across teams.

Skills

IEC 62304

ISO 80002-1

ISO 14971

IEC 60601

FDA Design Controls

SDLC

Risk management

Software validation

Data modeling

Cross-functional collaboration

Education

University degree in CS/Software/Biomedical/Systems/Engineering/Math/Physics

Advanced degree in relevant field

Job description

Intuitive Surgical in Sunnyvale, CA is seeking a Senior Quality Engineer to support the full software lifecycle for medical devices, from concept to commercialization. You will guide compliance with ISO and FDA standards, participate in design reviews, and ensure robust software verification and validation.

The role requires experience in regulatory quality systems, risk management, and cross-functional collaboration with R&D, manufacturing, and regulatory affairs to deliver safe, high-impact