Software QE

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. #LI-Hybrid

Qualifications

Skills/Job Requirements

Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or related discipline. 4+ years of Software Quality Engineering, Software Development, or Systems Engineering experience within 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, FDA QMSR/QSR, 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.

Preferred

Experience supporting AI/ML-enabled medical device software and CSA practices. Excellent communication, collaboration, and leadership skills with strong attention to quality and patient safety.