Software QE

About the role

As Intuitive expands its robotic-assisted surgical ecosystem, we are seeking a Software Quality Engineer to support the development and sustainment of Software as a Medical Device (SaMD), Embedded Software, Connected Medical Devices, and AI-enabled software solutions. The individual will provide quality engineering leadership across the software development lifecycle while ensuring compliance with

What you'll do

• Act as Software Quality representative for New Product Development and sustaining projects involving SaMD and Embedded Software
• Provide oversight of Design Controls, SDLC compliance, software verification and validation activities
• Review and approve requirements, architecture, software design, risk management, cybersecurity, traceability, test protocols, test reports, and release documentation
• Ensure compliance with IEC 62304, ISO 14971, ISO 13485, FDA QMSR, FDA Software Guidance, and applicable global regulations
• Participate in software risk management, hazard analysis, and risk control verification activities

What you need

• 4–7 yrs of experience
• Agile
• JIRA
• Vulnerability assessment
• Azure
• CI/CD
• Bug tracking
• B.Tech or B.E. or B.Sc or BCA

Good to have

• Machine learning
• Regulatory affairs