Intuitive Surgical is looking for a quality functional leader to support the development of next-generation surgical systems, ensuring products meet quality standards and regulatory requirements.
Requirements
- Expertise in medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls.
- Previous experience risk-based V&V, process validation, limit/challenge testing is required
- Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred
- Previous experience with running Verification & Validation Testing is preferred.
- 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.
Responsibilities
- Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
- Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
- Understand user needs and ensure they are translated into the design, while complying with usability and human factors standards and regulations.
- Partner with engineering to define design inputs, design outputs, and traceability matrices.
- Contribute to the strategy and execution of risk-based design verification and validation.
- Ensure reliable and scalable designs are transferred to manufacturing.
- Review design architectures, selections, requirements, and drawings from early design stages.
Other
- Requires a minimum of 8 years of related experience with a University Degree (in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, biomedical engineering), or 5 years of relevant experience and an Advanced Degree
- Ability to articulate complex information to teams, including executive management
