Intuitive
Manufacturing Engineer - Process Development
Intuitive, Sunnyvale, California, United States, 94087
Job Description
Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling instruments for minimally invasive robotic surgery. The role requires active participation in the sustaining manufacturing engineering organization to refine mechanical components, assemblies, process documentation, tooling/fixtures/test tools, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic instruments. Essential Job Duties
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 Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation. Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns. Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions. Create, maintain, and improve 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.
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Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling instruments for minimally invasive robotic surgery. The role requires active participation in the sustaining manufacturing engineering organization to refine mechanical components, assemblies, process documentation, tooling/fixtures/test tools, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic instruments. Essential Job Duties
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 Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation. Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns. Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions. Create, maintain, and improve 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.
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