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Senior Manufacturing Engineer

4 months ago

Burlington, United States BioTalent Full time

The Role:

This engineer will be hands-on in overseeing the production of advanced single-use medical devices.



Must Haves:

  • 10+ years' experience as a manufacturing engineer.
  • Experience in ISO 9000 or 13485 environments.
  • Hands on manufacturing experience with single use disposable medical devices.
  • Experience in upscaling production methods in a small company environment.
  • Proficiency in SolidWorks.
  • Plastics processing experience.
  • Ability to work in a startup environment, particularly in a fast paced, ever-changing environment.
  • BS in Manufacturing, Mechanical, Industrial or Plastics or other relevant engineering degrees.



Responsibilities:

  • Spearhead the development, execution, and validation of manufacturing processes to bolster process flow.
  • Lead verification and validation activities.
  • Optimize manufacturing process flow and floor layout to elevate safety, quality, and operational efficiency.
  • Develop and refine manufacturing tooling and fixtures.
  • Implement innovative automation solutions to streamline production processes.
  • Diagnose and rectify equipment malfunctions, devising effective corrective measures.
  • Develop and execute initiatives minimizing manufacturing costs and reducing scrap rates.
  • Analyze and address quality concerns, driving continuous improvement initiatives.
  • Collaborate with Quality Control to tackle supplier quality issues.
  • Formulate proposals for capital equipment investments.