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Mechanical Engineer III

Westborough, MA
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
  • Solidworks
  • Minitab
  • CAD
 
Requirement
  • 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.
  • 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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