Manufacturing Engineer, Stapler Reloads

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive is seeking a Manufacturing Engineer to contribute technical manufacturing, equipment design, and project management to a dynamic team creating precision stapling products for minimally invasive robotic surgery.

You will sustain manufacturing, set up lines, validate equipment (IQ/OQ/DQ/PQ), and drive continuous improvement to yield, cycle time, reliability, and cost. Travel to international sites, including Mexico and Malaysia, is required.

Responsibilities

• Hands‑on manufacturing sustaining support, setting up new manufacturing lines, duplication of manufacturing lines.
• Provide production line support for day‑to‑day engineering issues on manufacturing lines.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• 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 manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Ability to travel to international sites, including Mexico and Malaysia.

Job description

Job Description

Primary Function of the Position

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling products 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 stapling products.

Essential Job Duties

• Hands‑on manufacturing sustaining support, setting up new manufacturing lines, duplication of manufacturing lines.
• Provide production line support for day‑to‑day engineering issues on manufacturing lines.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• 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 manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Ability to travel to international sites, including Mexico and Malaysia.