Role Overview

The purpose of this position is to provide hands-on engineering support to the operations to produce high quality medical devices. This position will lead continuous improvement activities, implement and document manufacturing processes, devise engineering solutions to manufacturing problems and to help introduce new products and processes.

KeyResponsibilities

• Work with Global Research & Development (GRD), Project Engineering, Operations, Quality, Maintenance and other core functions to launch & support manufacturing processes.
• Design of tooling & fixturing, including qualification activities.
• Support existing equipment/processes, including process troubleshooting and validation.
• Equipment & infrastructure selection, including qualification activities (IQ/OQ/PQ)
• Implement flow & quality improvements before, during and after serial production launch
• Implement cost reduction ideas
• Author Engineering Change Orders

Key Requirements

• BS Degree in a Technical / Engineering discipline.
• 3- 5 years of Engineering experience in medical device manufacturing
• Process development & automation of assembly processes
• Problem Solving such as SSGB/SSBB, A3, DMAIC, Kaizen, etc
• Equipment / Tooling / Fixturing identification, design & qualification.
• Capital Expense ROI assessments & proposals.
• Intermediate MS Office skills including data analytics with focus on process yield monitoring & improvement.
• Experience using Solidworks for technical drawings.

Desired Experience

• Working with international teams, including willingness to travel internationally
• Cobot integration into existing manufacturing processes
• Experience in Quality Control & Inspection processes
• Prioir experience wotrking in a regulated manufacturing process

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