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Manufacturing Engineer

4 months ago

Burlington, United States BioTalent Full time

The Job:

Our client is looking to add a Manufacturing Engineer to their rapidly growing team. This engineer will play a hands-on role in supporting and enhancing manufacturing processes for cutting-edge single-use medical devices.



Must Haves:

  • Bachelor's degree in engineering.
  • Minimum of 5 years of experience in medical device manufacturing.
  • Proficiency in SolidWorks designing fixtures and tooling preferred.
  • Preferred experience in plastics processing (e.g., extrusion, injection molding, fiber forming).
  • Exposure to ISO 13485 standards is a plus.



Responsibilities:

  • Evaluate and enhance manufacturing process flow and facility layout to improve safety, quality, and efficiency.
  • Diagnose equipment issues and devise corrective measures.
  • Develop and execute validation protocols (IQ/OQ/PQ).
  • Collaborate with the product development team to design manufacturing tooling and fixtures.
  • Optimize production processes through methods.
  • Devise and deploy automation solutions.
  • Collaborate with Quality Control to address production and supplier quality concerns.
  • Provide direct support to production staff to ensure compliance with Good Manufacturing Practices and Standard Operating Procedures.