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Manufacturing Engineer

Manufacturing Engineer

CompanyIntuitive Surgical
LocationSunnyvale, CA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelJunior, Mid Level

Requirements

  • Proven technical, systematic and troubleshooting skills
  • Prior experience with technical writing
  • Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience
  • Experience as design or manufacturing engineer supporting products

Responsibilities

  • Create, maintain, and improve ‘low to high-volume’ manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
  • Apply engineering concepts to the optimization of equipment and procedures to achieve better maintainability, reliability, capacity, and availability of equipment.
  • Diagnose equipment breakdowns to define and implement improvement strategies.
  • Perform installation, repair, and upkeep services for a variety of equipment either in the fields of mechanics and electronics.
  • Design, document, procure, qualify, implement, and improve fixtures, tools, or equipment.
  • Responsible for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA.
  • Responsible for the validation and qualification of manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ/DQ).
  • Conduct testing of software releases before deploying on manufacturing line.
  • Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
  • Maintain compliance with medical device quality system including corrective action closure and Change Order implementation.
  • Conduct SAP transactions relevant to process or equipment operations.
  • Specify, fit, and integrate new equipment and ensure it is working properly, along with required documentation.
  • Improve existing documentation for equipment installation, repair, and upkeep.

Preferred Qualifications

  • Mechanical CAD software experience (SolidWorks or equivalent) is a plus
  • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
  • Able to travel periodically