Software QE

Intuitive · Bangalore

Source and collection record

Last observed by our collector: 9 October 2026 at 12:42 am IST. This is not a manual review or a confirmation from the employer.

Employer requisition: JOB218416

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Collected role description

Primary Function: 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 global medical device regulations and industry standards. This is not a software testing role. Roles and Responsibilities: 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. Support cybersecurity risk management in accordance with FDA guidance, AAMI TIR57/TIR97, and NIST frameworks. Provide quality oversight for Agile, DevOps, CI/CD, defect management, CAPA, root cause investigations, and software changes. Ensure end-to-end traceability from User Needs through Software Verification and Validation. Support regulatory submissions, audits, inspections, and post-market software quality activities. Drive continuous improvement initiatives and Computer Software Assurance (CSA) adoption. #LI-Hybrid