Intuitive Surgical Careers
Senior NPI Manufacturing Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183035
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Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Contribute your technical manufacturing, equipment design and project management skills to a dynamic development team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments.
Roles and Responsibilities:
• Create, maintain and improve pilot “mid-volume” manufacturing assembly line, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Provide production support through successful and sustained project launch.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
• Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
• BS in Engineering required, MS/PhD preferred.
• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
• Prior experience with Sensor Design / Mechatronics / Robotics / automated equipment is a plus
• Prior responsibility for process, equipment or product validation/verification. Single use/disposable medical device experience a plus
• CAD experience (preferred Solidworks).
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
• Able to travel periodically to suppliers or Intuitive Mexicali plant
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.