Manufacturing Engineer
Developed robust processes for medical device manufacturing, ensured compliance with all quality and regulatory requirements, sustained support for existing production processes, created/maintained work instructions and BOMs, established manpower requirements, process validations and verifications, PFMEA, project management, new product introductions, developed lean metrics, and provided subject matter expertise in continuous improvement initiatives throughout the facility.Operated within a… Show more Developed robust processes for medical device manufacturing, ensured compliance with all quality and regulatory requirements, sustained support for existing production processes, created/maintained work instructions and BOMs, established manpower requirements, process validations and verifications, PFMEA, project management, new product introductions, developed lean metrics, and provided subject matter expertise in continuous improvement initiatives throughout the facility.Operated within a FDA 21 CFR Part 820 / ISO 13485 regulated class III medical device manufacturing facility.Maximized process efficiencies by analyzing layout of equipment, workflows, assembly methods and work force utilization using lean principles. Show less