Manufacturing Production Technician

Position Summary The Manufacturing Production Technician position performs all activities associated with manufacturing blended polymer, responsible for maintenance activities associated with repairs, PM’s and calibrations, assists engineering with the installation and qualification of equipment and supports manufacturing operations for the production of commercial medical devices according to written specifications and manufacturing instructions. Specific Job Functions o Responsible for performing the manufacturing operation steps for the processing of our blended polymer for pre-clinical, clinical and commercial sites. o Work with supply chain to maintain raw material supplies necessary to meet demand/forecast for blended polymer production. o Complete assigned Preventative Maintenance (PM’s) items for equipment in commercial and pilot production areas in a timely manner. o Support and manage the calibration process of equipment, as required. o Help maintain the facility working with external contractors in helping quote, organize and manage their activities when they are on site completing repairs. o Perform and/or support the installation and qualification activities (IQ/OQ/PQ) for new equipment at the direction of engineering in accordance with approved documentation. o Assist supervisors/engineers on lean process improvement, lean waste reduction and other tasks related to manufacturing activities. o Support the assembly of medical devices in a controlled environment in accordance with detailed assembly instructions, processes and procedures. · Excellent dexterity and fine motor skills to work on small parts and intricate assemblies, including the use of small hand tools. · Ability to perform assembly work utilizing microscope or magnification. · Confident in operating large and small pieces of semi-automated and automated equipment. o Follow documented policies and procedures as designated by the company’s Quality System. o Observe, maintain, coordinate and complete standard work. Train Production Assemblers, as needed. o Complete required documentation (batch records; equipment, inspection, and test forms; labeling forms) relating to business or regulatory requirements. · Detail oriented ensuring all written documentation is complete, legible, and accurate. · Ensure all production data entered in the eERP is accurate and complete. o Maintain a clean and organized work area to facilitate manufacturing functions. o Work closely and communicate with other employees to build a cohesive production team within a dynamic, fast paced environment. o Communicate with supervisors/engineers on product performance, functionality issues and procedure updates. o Understand and perform basic calculations. o Competent working with computers and portable electronic devices. · Comfortable accessing documents and information in both the eQMS and eERP systems. Supplemental Job Functions o Accurately pull and count components for manufacturing work orders. o Deliver materials to specified work areas. o Ship and receive palletized product for further processing. o Print, develop and validate product labels. Physical Requirements o Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. You may be required to provide verification of latest eye exam. o Good manual dexterity. o Ability to sit for extended periods during the shift. o Ability to lift up to 50 lbs. Minimum Qualifications, Education & Work Experience o High school diploma with equivalent relevant work experience is required. Degree in chemistry or a related technical area with relevant work experience is preferred. o 3 years experience as a Production or Engineering Technician in the medical device, pharmaceutical or other regulated industry, is preferred. o Ability to understand and execute established written procedures. o Good documentation and record keeping skill…

View the full posting and apply