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Senior Quality Engineer

3 months ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position:

Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for an exceptional quality functional leader to support the projects associated with the development of next generation innovation products.

Senior Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Senior Quality engineer will provide expertise and guidance to the team on design control and risk management, Software Development Life Cycle, and Design for Reliability and Manufacturing. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements.

Roles & 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.

  • Participate and support the development of product risk management file, to examine and assess the product risks associated with user, design, process and supplier.

  • Ensure reliable and scalable designs to transferred to manufacturing

  • 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.

  • 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.