Manufacturing Engineer

Title: Manufacturing Engineer 
Location: Westborough, MA 01581
Duration: 6-7 months contract
This is a Manufacturing Engineer position. 
The 3 must haves are: 
1. Process development 
2. Validation Experience 
3. Lean Manufacturing 
Industry experience: 
*Medical Device 
There is a new automation line, it is developed, needs someone to work on process development, validation, and run test equipment. 
Candidate must be willing to work in a clean room. 
Experience with this software is a +: 
Documentation Software System 
·         Prefer local candidates, if not local, candidate must travel and relocate on own expense. 
·         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. 
·         When your candidate is selected for a phone or in-person meet and greet, please prep your candidate to have specific examples on their experience in process development, validation and lean manufacturing. 
·         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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