Role Overview

The purpose of this position is to develop and implement processes to ensure quality, delivery and cost objectives of our product lines. This position will assist in converting manual processes to more efficient automated processes that enable volume scale up.

KeyResponsibilities

• Work with Global Research & Development (GRD), Project Engineering, Operations, Quality, Maintenance and other core functions to launch & support serial production
• Design of tooling & fixturing, including qualification activities
• Equipment & infrastructure selection, including qualification activities (IQ/OQ/PQ)
• Product Line / Workcenter layout when (semi) automated processes are in use
• Work with motors, PLCs, HMIs, and other industrial systems
• Support existing automated equipment/processes
• 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.
• Engineering experience in medical device manufacturing or other regulated environment
• Equipment development to enable automation of existing manufacturing processes
• Project Management such as A3, Gantt chart, etc
• Ability to work with outside integrators in a liaison role
• Equipment / Tooling / Fixturing identification, design & qualification
• Process development & qualification of automated assembly processes
• Capital Expense ROI assessments & proposals
• Cobot integration into existing manufacturing processes
• PLC based automated equipment/process development with user friendly HMIs

Desired Experience

• Working with international teams
• Machine monitoring & learning knowledge
• Problem Solving such as SSGB/SSBB, A3, DMAIC, Kaizen, etc
• Experience working in a cleanroom environment
• Experience working in a machining/industrial equipment environment driving OEE as KPI
• Experience in a IIoT (Industrial Internet of Things) environment with focus on data collection & analytics
• Understanding of FDA and ISO standards
• Programming experience in C++, Python, SQL or similar language*
• Industrial electrical panel design*
• PLC programming (Allen-Bradley, Siemens, Beckhoff or similar)*
• HMI/SCADA programming (Unitronics, Allen-Bradley, or similar)*
• Stepper motors and controllers (Schneider Electric or similar)

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