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Quality Engineer 4

2 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 a strong quality functional leader to support the projects associated with the development of next generation products.

The Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional product development team. This role provides expertise and guidance on design controls, risk management, process validation, and design for reliability and manufacturing. Additionally, the position ensures that developed products meet quality standards consistent with Intuitive’ s quality processes and all external design control and regulatory requirements.

Roles & Responsibilities:

  • Design Controls and Risk Management:
    • 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.
  • Design Transfer:
    • 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.
  • Regulatory Support:
    • Support Regulatory Affairs with creating submissions and responding to submission questions.
    • Support internal and external audits, including preparation and direct interaction with auditors.