Senior Quality Engineer – Reliability & Data Analytics
| Company | Intuitive Surgical |
|---|---|
| Location | San Francisco, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- Requires a minimum of 8 years of related experience with a University Degree (in electrical, mechanical or system engineering, math, or physics), or 5 years of relevant experience and an Advanced Degree (in electrical, mechanical or system engineering, math, or physics)
- Experience of at least 3 years in electromechanical systems
- Expertise in medical device standards such as ISO 14971, IEC 60601, and FDA Design Controls
- Solid understanding of design control and risk management from early design and development through commercialization
- Demonstrated experience with electromechanical systems from concept through launch
- Experience with medical standards compliance, including ISO 13485, ISO 14971, and FDA Quality System Regulations, with a focus on design controls and design optimization
- 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
- 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
- Participate in and support the development of the product risk management file, analyzing and assessing product risks associated with user, design, process, and supplier
- Ensure reliable and scalable designs are transferred to manufacturing
- Review design architectures, selections, requirements, and drawings from early design stages
- Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production
- Assist in supplier selection, qualification, certification, and performance improvement
- Contribute to new product development Technical Reviews and Design Reviews
- Support Regulatory Affairs with creating submissions and responding to submission questions
- Support internal and external audits, including preparation and direct interaction with auditors.
Preferred Qualifications
-
No preferred qualifications provided.