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
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.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
