Job 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.
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