Manufacturing Engineer

4 weeks ago


Lexington, Kentucky, United States T2 Biosystems Full time
Job Summary

We are seeking a highly skilled and detail-oriented Manufacturing Engineer to join our team at T2 Biosystems. As a key member of our instrument manufacturing operations, you will be responsible for promoting product quality, supporting instrument manufacturing, and driving continuous process improvement.

The ideal candidate will have a strong background in electromechanical assembly design and manufacturing, with a minimum of 5 years of experience in an FDA-regulated environment. You will be responsible for supporting the instrument manufacturing team, participating in developing and implementing manufacturing quality processes, and driving regular review of the manufacturing process to identify opportunities for improvement.

You will also be responsible for participating in the inspection of finished products, in-process assemblies, and raw materials, and working with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions. Additionally, you will assist in driving timely completion of Non-Conformances while preventing repeat occurrences, and partner with operations and quality leaders on the regular review of quality metrics for all instrument manufacturing processes.

Key Responsibilities:

  • Support the instrument manufacturing team in developing and implementing manufacturing quality processes
  • Participate in the inspection of finished products, in-process assemblies, and raw materials
  • Drive regular review of the manufacturing process to identify opportunities for improvement
  • Work with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions
  • Assist in driving timely completion of Non-Conformances while preventing repeat occurrences
  • Partner with operations and quality leaders on the regular review of quality metrics for all instrument manufacturing processes

Requirements:

  • Bachelor's Degree in engineering-related discipline required, Mechanical or Electrical Engineering preferred
  • Minimum of 5 years of relevant manufacturing experience in an FDA-regulated environment required
  • Strong electromechanical assembly design/manufacturing experience required
  • ASQ or Six Sigma Certification or equivalent desired
  • Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required
  • Familiarity with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations required

T2 Biosystems is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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