Manufacturing Engineer
Company | Intuitive Surgical |
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Location | Sunnyvale, CA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Junior, 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