Intuitive Surgical seeks a Software Quality Engineer in Bengaluru to oversee quality engineering across the software development lifecycle for medical devices, including SaMD and embedded software. The role ensures compliance with global regulations and provides quality leadership for new product development and sustaining projects.

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, design, risk management, cybersecurity, traceability, test protocols, and release documentation
Participate in software risk management, hazard analysis, risk control verification, and regulatory submissions
Drive continuous improvement initiatives and Computer Software Assurance adoption across the development lifecycle

Requirements

Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related discipline
4+ years of Software Quality Engineering, Software Development, or Systems Engineering experience in medical devices
Hands-on experience with SaMD, Embedded Software, Connected Devices, or Robotics Software
Strong knowledge of IEC 62304, ISO 13485, ISO 14971, FDA Design Controls, and software lifecycle compliance
Experience with Agile methodologies and tools such as Jira or Azure DevOps
Understanding of Medical Device Cybersecurity, Secure SDLC, Threat Modeling, and Vulnerability Management
Experience with traceability, risk-based testing, software reliability, and release management

Software QE

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