Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences is hiring: Manufacturing Engineer in Clevel
Katalyst Healthcares & Life Sciences, Cleveland, OH, US
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