Software QE
BengaluruFull-time4–7 yrsPosted 1 week ago
Mid-level software engineering role at Intuitive in Bengaluru. Needs 4+ years and a B.Tech, B.E. or B.Sc.
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
- Agile
- JIRA
- Vulnerability assessment
- Azure
- CI/CD
- Bug tracking
Good to have
- Machine learning
- Regulatory affairs