Intuitive Surgical is looking to solve the problem of developing next generation innovation products that meet quality standards consistent with their quality processes and external design control and regulatory requirements.
Requirements
- Solid understanding of design control and risk management from early design and development through commercialization
- Demonstrated experience with electromechanical system 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
- Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in electromechanical systems and/or software design and development
- Able to navigate quality system with minimal oversight on personal projects
- Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges
- Solves complex problem with minimal oversight
Responsibilities
- Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products
- Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.
- Understand user needs and assure they are translated to the design, while ensuring compliance to 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.
- Review design architectures, selections, requirements, and drawings from early design
- Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.
Other
- Minimum Bachelor’s degree in electrical, mechanical or system engineering, math, or physics
- Able to articulate complex information to teams, including executive management
- Support internal and external audits, including preparation and direct interaction with auditors
- Support Regulatory Affairs with creating submissions and responding to submission questions
- Travel requirements not specified
