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Manufacturing Engineer
Manufacturing EngineerKatalyst Healthcares & Life Sciences • Cleveland, OH, United States
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Manufacturing Engineer

Manufacturing Engineer

Katalyst Healthcares & Life Sciences • Cleveland, OH, United States
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  • [job_card.full_time]
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Job Summary :

  • Seeking a Manufacturing Engineer with medical device experience to support and improve manufacturing processes in a regulated environment.

Roles & Responsibilities :

  • Develop and optimize manufacturing processes
  • Support new product introductions and production scaling
  • Perform process validations (IQ / OQ / PQ)
  • Troubleshoot manufacturing issues and drive continuous improvement
  • Ensure compliance with FDA, ISO 13485, and GMP requirements
  • Collaborate with Quality, R&D, and Operations teams
  • Education & Experience :

  • Bachelor's degree in Engineering or related field
  • 3+ years manufacturing engineering experience in medical devices or regulated industry
  • Knowledge of FDA regulations, GMP, and process validation
  • Strong problem-solving and communication skills
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