Talented Process Engineer for Enhancing Medical Device Production
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Drive innovation in medical device manufacturing as a proficient Process Engineer. Focus on optimizing and validating processes to ensure regulatory compliance and outstanding product quality throughout the lifecycle. We're searching for a skilled Process Engineer with 5 years of dedicated experience in the medical device industry. This role encompasses developing, implementing, and optimizing production processes while adhering to strict regulatory standards. Your collaboration with R&D, Quality, and Production teams will establish the groundwork for successful product introduction and continuous improvements. Key Responsibilities:
- Develop and optimize production processes for medical devices
- Ensure regulatory compliance with FDA and ISO standards
- Lead validation efforts (IQ, OQ, PQ) and maintain documentation
- Conduct root cause analysis and implement CAPA
- Train production staff on new processes and improvements
- Bachelor’s degree in Mechanical or Industrial Engineering
- 5 years in medical device process engineering
- In-depth knowledge of Lean Manufacturing
- Familiarity with Six Sigma tools
- Strong analytical and problem-solving expertise