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Manufacturing Engineer

Westborough, MA
The 3 must haves are: 
1. Process development 
2. Validation Experience 
3. Lean Manufacturing 

Industry experience: 
*Plastics & sealing/welding technologies 
*Adhesive UV bonding and curing 
*Medical Device 

New product introductions involving manufacturing process development and validation utilizing various equipment and six methodologies. 

Candidate must be willing to work in a clean room. 

Experience with this software is a +: 
Documentation Software System 
Looking for a candidate with a background in mechanical or automation engineering. 
Self-starter and takes initiative, be assertive, and manage schedule on assigned projects from inception to completion. 
Able to manage and solve complex problems with limited guidance. 
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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