OverviewThe Manufacturing Engineer 1 is responsible for providing technical support for the day-today production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.Responsibilities• Provides process support for extrusion department• Hands-on position with visibility on the manufacturing floor• Requires a high level of interaction with the production, product development, and quality teams• Supports product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives• Supports production departments’ manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence• Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects• Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation• Manages multiple technically oriented projects through coordinating internal and external resources• Collaborates on product complaint resolutionQualifications• High School Diploma with applicable experience is required; Bachelor’s degree in Engineering/Plastics Engineering preferred• 3+ years of extrusion process development experience• 5+ years of work related to polymer processing preferred• Process validation (IQ, OQ, PQ) preferred• Equipment qualification (IQ, OQ, PQ) preferred• Fundamental understanding engineering principles• Extrusion process development / Extrusion Tooling Design• Mechanical aptitude preferred• Understanding of ISO 13485:2016 preferred• CFR, FDA, OSHA, environmental regulations preferred• Proficiency at using Microsoft Office applications• Troubleshooting and problem-solving skills• Equipment / process troubleshooting preferred• Experience with blue print reading preferred• Design of Experiments / Six Sigma preferredPhysical Requirements:• May exert up to 20 pounds of force frequently, and/or a negligible amount of force constantly to move objectsRequisition ID2024-15320Posting Date1 month ago(9/30/2024 11:22 AM)Job Location(s)Canton IL United StatesJob LocationsUS-IL-CantonTravelLess than 10%Shift Type1st shiftPosition TypeFull TimeCompanyCook Inc - CantonCategoryEngineering