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Manufacturing Engineer -Lean Mfg. & Process development (medical devices)

Westborough, MA
Will consider non-degree'ed engineers, usually these candidates have many years of experience behind them
 
With a degree, need to have a minimum of 2 years of experience, an internship is not enough.
 
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Looking for a candidate with a background in mechanical or automation engineering.
A working knowledge of the Bio-Pharmaceutical industry is beneficial.
Possess experience with process development in a lean manufacturing area.
Can write and execute protocols including installation qualifications (IQ), operational qualification (OQ) and performance qualification (PQ).
In addition, they should have experience in composing work instructions and can provide guidance and training to others.
Candidate should have experience working in a ISO-13485/9000 cGMP ISO 7 clean room environment.
Candidate should have a strong work ethic that will drive results in an expeditious manner towards a positive outcome.
Can collect and interpret data to develop capable manufacturing process that will yield a consistent quality product repeatedly.
Additional skills in web converting/handling, heat sealing and system automation is a plus.
Qualifications would consist of a bachelor degree or equivalent experience.
 
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