Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200667
Primary Function of Position:
Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in sustaining manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.
- Create, maintain and improve “mid-volume” manufacturing assembly lines, 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 line support for day-to-day engineering issues on core instrument lines
- 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 core instruments.
- 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 / MS degree in Engineering discipline or equivalent work experience.
- 5-7 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
- Prior responsibility for process, equipment or product validation/verification.
- Prior experience designing automated equipment, complex mechanism manufacturing is 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