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
Requirements:
• Bachelor’s degree in...