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Manufacturing Engineer


$90,000    Hopkinton, MA    Permanent    Job Number:189405    Posted:2/15/2019

  • Provide engineering support to product manufacturing floor
  • Analyze processes and equipment and identify opportunities for improvement
  • Investigate and resolve technical problems for materials, process, and product.
  • Develop, document and initiate production processes for new products
  • Assist with root cause analysis to identify quality or cost improvement opportunities and implement corrective action
  • Develop process validation protocols, perform testing, and evaluate results, using statistical techniques
  • Ensure compliance to Design Controls such as CGMP, FDA, QSR, MDD
  • Participate in product failures and complaints investigations
  • Design, manufacture or coordinate manufacture of new, replacement or alternative jigs, fixtures or equipment
  • Work with other departments in the transition of new products into Manufacturing.
  • Manufacturing process conceptualization and development

 

Requirements

  • 4 +years of experience in manufacturing engineering of medical devices
  • BS in mechanical engineering or other related discipline
  • Knowledge and application of statistical methods strongly desired
  • Knowledge of FDA regulations
  • Working Knowledge of LEAN Principles
  • Knowledge of manufacturing processes such as joining, machining, fabrication, finishing, and plating



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