Manufacturing Mechanical Engineer

Manufacturing Mechanical Engineer

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 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.

Essential Job Duties

• Create, maintain and improve "high-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.
• Independently and proactively determines and analyzes trends for equipment performance
• 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 i.e. resolve emergency and unscheduled problems/repairs of equipment.
• 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.
• Able to travel periodically to suppliers or Intuitive Mexicali plant

Required Skills and Experience

• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
• Strong technical analytical and troubleshooting skills.
• Prior experience with managing product and process changes.
• Strong organizational skills and proven ability to work on fast-paced projects simultaneously.
• Prior experience with technical writing.

Required Education and Training

• BS / MS degree in Engineering discipline or equivalent work experience.
• 3+ years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.

Preferred Skills and Experience

• Prior responsibility for process, equipment or product validation/verification.
• Prior experience designing automated equipment, complex mechanism manufacturing is a plus
• CAD experience (preferred Solidworks).
• Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, testing of optical devices, and fiber routing is preferred
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus