Overview The 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 resolution Qualifications • 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 preferred Physical Requirements: • May exert up to 20 pounds of force frequently, and/or a negligible amount of force constantly to move objects Requisition ID2024-15320 Posting Date3 days ago(9/30/2024 11:22 AM) Job Location(s)Canton IL United States Job LocationsUS-IL-Canton TravelLess than 10% Shift Type1st shift Position TypeFull Time CompanyCook Inc - Canton CategoryEngineering