Senior Quality Engineer
| Company | Intuitive Surgical |
|---|---|
| Location | San Francisco, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Requires a minimum of 8 years of related experience with a University Degree (in Computer science, software engineering, biomedical engineering, or 5 years of relevant experience and an Advanced Degree (in electrical, mechanical or system engineering, math, or physics)
- Expertise in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.
- Experience with risk-based software validation, software test automation, and SDLC processes.
- Knowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA).
- Ability to navigate quality systems with minimal oversight on individual projects.
- Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
- Ability to solve complex problems with minimal oversight.
- Ability to articulate complex information to teams, including executive management.
Responsibilities
- Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
- Participate in design reviews, code reviews, defect tracking and reviews, and software validation activities.
- Ensure adherence to software development lifecycle (SDLC) processes, including Agile methodologies.
- Support risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1.
- Collaborate with R&D and testing teams to identify and mitigate software defects.
- Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.
- Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
- Partner with engineering to define design inputs, design outputs, and traceability matrices.
- Support Regulatory Affairs with creating submissions and responding to submission questions.
- Support internal and external audits, including preparation and direct interaction with auditors.
- Drive continuous improvement in software quality processes and methodologies.
- Work closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery.
- Implement test automation strategies to improve efficiency and coverage.
Preferred Qualifications
- Preferred experience in AI/ML-based medical software (SaMD/embedded AI).