JVT Advisors

Manufacturing Engineer II

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Location: Burlington, Massachusetts
Employment Type: Direct Hire

Job Description

The Manufacturing Engineer II will provide technical floor support to instrument and consumable manufacturing operations to ensure on-time shipments of high-quality clinical and biotechnology products. In addition, the manufacturing engineer will work on process/product improvements as well as transfer of new products into manufacturing operations. The manufacturing engineer will also contribute to the investigation of technical issues in manufacturing to ensure continuous improvement.

  • Provide day-to-day technical floor support to instrument/consumable operations by investigating and resolving issues which arise during the manufacturing of products.
  • Measure/inspect electromechanical components for form, fit, and function and disposition nonconforming product.
  • Update/create manufacturing documentation (SOPs, BOMs, forms and drawings) via the DCN process which conform to Quality System Regulations (QSR’s).
  • Research, specify and procure new equipment for existing or new processes/assemblies. Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
  • Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA) and Continuous Improvement Studies/Evaluations.
  • Lead the transfer of new products and processes to manufacturing. Provide training to personnel on new products/processes as necessary. Contribute to continuous improvement programs to reduce cost and cycle times of products.
  • Examine and implement lean manufacturing techniques.

Qualifications:            

  • Bachelor’s Degree in Mechanical Engineering
  • 2-5 years of manufacturing or mechanical engineering experience in a regulated industry; medical device experience is helpful
  • Machine/Tool design experience
  • Experience utilizing SolidWorks/SolidWorks PDM
  • Knowledge of QSR and ISO regulations is a plus
  • Good written and oral communication skills, including ability to communicate effectively at all levels of the organization

 

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Yhoumey Won

Recruiter

Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.

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