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