Katalyst CRO
Manufacturing Engineer Job at Katalyst CRO in Warsaw
Katalyst CRO, Warsaw, IN, United States, 46580
Job Description
We are looking for a skilled Manufacturing Engineer with experience in the medical device industry. The ideal candidate will be responsible for improving manufacturing processes, ensuring product quality, and supporting production teams to meet regulatory and safety standards.
Responsibilities
- Develop and optimize manufacturing processes for medical devices.
- Ensure compliance with FDA, ISO 13485, and other regulatory standards.
- Troubleshoot production issues and implement corrective actions.
- Support validation and documentation activities (IQ, OQ, PQ).
- Collaborate with design, quality, and production teams.
Requirements
- Bachelor's degree in engineering (Mechanical, Industrial, or related field).
- 6+ years of experience in medical device manufacturing.
- Knowledge of GMP, FDA regulations, and ISO 13485.
- Strong problem-solving and communication skills.
Employment type: Contract
Industry: Pharmaceutical Manufacturing