Manufacturing Equipment Engineer 3
Core
Develop and execute manufacturing validation processes for high volume automation assembly lines creating precision surgical instruments and accessories.
Role type
Manufacturing Equipment Engineer
Builds
High volume automation assembly lines for surgical accessories
Domain
Medical device manufacturing / Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, capability analysis, equipment validation (IQ/OQ/PQ/PPQ), Design for Manufacturability, Design for Reliability, continuous improvement, Design of Experiments, BOM management, workflow process creation, manufacturing plan development, detailed work instructions creation, PLC programming, robotics controls, automated line controls, fixture design, hand tool qualification, machine design specification, critical feature inspection, test checkpoint integration, ISO9001/13485 compliance, CAD (SolidWorks, AutoCAD)
Preferred skills
Medical device manufacturing experience, New product introduction/development, Controls/Robotics programming, high volume automated assembly processes, ISO9001/13485 experience
Technologies
PLC, I/O Components, SolidWorks, AutoCAD
Responsibilities
Function as plant contact for machine integrator in development, evaluation, and shipment of automation lines; Validate, maintain, and improve high volume automation manufacturing assembly lines including fixtures, hand tools and manufacturing equipment; Determine and incorporate critical feature inspection and test checkpoints into process; Develop manufacturing line equipment specifications to guide machine design; Develop, maintain, and execute IQ/OQ/PQ and PPQ documentation; Identify and implement continuous improvement projects to improve first pass yield, cycle time reduction, product reliability, and cost reduction; Take responsibility for developing and maintaining compliance with the quality system; Provide design engineers with Design for Manufacturability and Design for Reliability input; Create and maintain controlled documents such as BOMs, workflow processes, manufacturing plan and detailed work instructions; Utilize design of experiments to determine best parameters for equipment operation.
Seniority
Mid-Senior, hands-on IC