Manufacturing Engineer - Medical Devices

Job Title: Manufacturing Engineer Medical DevicesLocation: Plymouth, MN & Irvine, CA & Boston, MAJob SummaryWe are seeking a Manufacturing Engineer to support production processes in a regulated medical device environment. This role focuses on improving manufacturing efficiency, ensuring product quality, and supporting new product introduction while maintaining compliance with industry standards.Key ResponsibilitiesDevelop, implement, and optimize manufacturing processes for medical devicesSupport production activities, troubleshooting issues and improving yieldAssist with new product introduction (NPI) and process transfer to manufacturingCreate and maintain work instructions, SOPs, and process documentationCollaborate with Quality, R&D, and Operations teams to ensure compliance and performanceSupport process validation activities (IQ/OQ/PQ)Drive continuous improvement initiatives (Lean, Six Sigma)Ensure compliance with FDA, ISO 13485, and GMP requirementsRequired QualificationsBachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related field)2 5 years of experience in medical device manufacturing or regulated industryKnowledge of manufacturing processes and quality systemsUnderstanding of FDA regulations and ISO 13485 standardsStrong problem-solving and analytical skills