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.
Key Responsibilities
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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