This position is responsible for operating essential, complex extrusion machinery to produce quality product to documented specifications. The primary function is to maintain the equipment, raw materials, color, packaging and other related materials necessary to run extrusion lines efficiently and execute work scheduled for production. Essential Duties and Responsibilities + Responsible for the safe operation of equipment along with the safety of any persons who may come in contact with the equipment. Proactively communicate and address safety concerns per SOP. + Maintain a clean and safe working environment including, but not limited to, ensuring the necessary safety features and guards are included on all equipment. + Perform the operation of extrusion machinery, complete existing Preventative Maintenance (PM) functions, recommend PM enhancements and perform troubleshooting logic. Read and interpret machine drawings and mechanical blue prints. Accurately measure work in process (WIP) and finished assemblies in inches and centimeters. + Operate a variety of complex equipment while achieving quality standards, production goals, and cost objectives. + Perform changeovers and machine repairs as needed. + Ability to run all operations within guidelines of the Development Product Record (DPR) or Work Instruction (WI). + Participate in Project Teams to provide technical support to Engineering and Product Development. + Establish parameters on all extrusion equipment to ensure consistently exceptional product quality. + Perform complete set-up, adjustments, start-up, and shutdown of all equipment in the area. + Participate in design of new tooling and equipment by providing technical input as required. + Qualify new tooling and processes by means of performing validation testing when required. + Act as point-person to identify opportunities for process improvement, quality enhancements, and efficiency increases. Recommend actions to supervision for consideration and participate in implementation if necessary. + Communicate technical issues in a timely manner to all levels (managers, co-workers, maintenance, engineers, etc.). + Maintain all appropriate documentation as applicable to extrusion equipment, product, inventory management (raw resin), and WI in compliance with all internal and external regulatory standards. + Inspect raw materials and products to ensure there are no visible defects; take corrective action as needed. + Assist in training of other operators. + May perform other duties as assigned. + Manages in order to ensure compliance with all relevant regulatory/legal requirements. + Maintain compliance to all quality requirements to ensure quality products are produced Responsibility for Work of Others None Qualifications QUALIFICATIONS – The requirements listed below are representative of the knowledge, skill, or ability required. Education and Experience + High School/GED Level of Degree in the general field of study + 5 years of demonstrated experience in extrusion process, including equipment knowledge and familiarity with thermos plastics, preferably within the medical device industry + N/A Certificates Required + Associate’s Degree in technology with an emphasis on plastics or a related discipline is preferred Skills/Knowledge + Strong mathematical aptitude, such as the ability to calculate flow rate and take measurements of circumference + Ability to take direction + Self-motivated, flexible, and cooperative + Excellent hand and eye coordination + Manual dexterity and mechanical reasoning skills + Demonstrated decision-making skills and effective problem-solving abilities + Knowledge of correct machine set-up and operation to meet quality and efficiency standards + Lean manufacturing experience including 5S methodologies + Proficient use of Microsoft Office + Exceptional interpersonal skills + Strong organizational skills + Strong communication skills (written and verbal) both internally and externally + Ability to read and interpret documents such as customized blue prints, safety rules, operating and maintenance instructions, and procedure manuals + Ability to write routine reports and correspondence with an emphasis on completing paperwork including DPR’s, inventory management forms, data collection, technically accurate feedback, and any other documentation utilized to maintain proper product traceability. PHYSICAL/WORK REQUIREMENTS The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job: + Work safely and follow all OSHA regulations and company safety policies and procedures. + For all on-the-job injuries or accidents, must notify manager/supervisor immediately. + Exposure to a controlled Manufacturing Clean Room Environment + Ability to frequently lift and/or move up to 35 lbs. + Ability to occasionally lift and/or move up to 50 lbs. + Ability to regularly stand and walk to perform production tasks. + Required to perform repetitive movement while demonstrating proficient hand and eye coordination, hand dexterity, and good vision. + Ability and willingness to work overtime, as required + Continual attention to the accuracy of documentation