Software QE

Role overview

Software QE at Intuitive

Act as Software Quality representative for New Product Development and sustaining projects involving SaMD and Embedded Software.

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.

Responsibilities

• 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

Employment details

• Location: Bengaluru [INDIA] [India]

Benefits

• The individual will provide quality engineering leadership across the software development lifecycle while ensuring compliance with global medical device regulations and industry standards.

Additional role details

• This is not a software testing role.
• Roles and