Intuitive Surgical is looking for a Senior Quality Engineer to support the development of next-generation innovation products, ensuring they meet quality standards and regulatory requirements from concept through commercialization.
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 is required.
- Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
- Review design architectures, selections, requirements, and drawings from early design
- Contribute to new product development Technical Reviews and Design Reviews.
- 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
- Provide expertise and guidance to the team on design control and risk management, Software Development Life Cycle, and Design for Reliability and Manufacturing.
- Ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements.
- 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.
- Participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.
Other
- Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in electromechanical systems and/or software design and development
- Education: Minimum Bachelor’s degree in electrical, mechanical or system engineering, math, or physics.
- Able to articulate complex information to teams, including executive management.
- Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products
- Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.
