Operator I

Medical Device Assembler This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Key Responsibilities: Perform routine assembly, repair, and testing operations according to specified and standardized procedures. Work under close supervision with all work being continually reviewed for quality and accuracy. Ensure relevant job documentation for cell operations and functions is accurate, complete, and up to date. Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and verbal formats. Maintain a positive and professional attitude when interacting with internal and external customers, including facility tours. Follow all safety guidelines and utilize appropriate safety devices during operations. Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability goals. Maintain accurate production records, traveler documents, and quality documentation to ensure traceability of all parts and products. Support investigations and resolution of quality issues to ensure product integrity. Demonstrate a basic understanding of Lean Manufacturing principles. Participate with Manufacturing Supervisors and Managers in setting and monitoring individual and cell performance goals and metrics. Support divisional initiatives and comply with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Required Skills and Qualifications: Ability to read, understand, and follow written procedures and verbal instructions. Ability to utilize electronic data collection systems and computer software applications. Strong organizational skills with the ability to prioritize work based on timing, importance, and production requirements. Ability to handle and maneuver small components and parts with precision. Ability to make sound decisions and judgments with minimal supervision. High School Diploma or equivalent preferred. Manufacturing Environment Requirements: Must adhere to strict cleanroom and gowning requirements. Clothing must be non-shedding, clean, and free of loose fibers, frayed hems, glitter, sequins, or other detachable materials. Loose knit garments, fleece, sweaters, and similar materials are not permitted. Clothing must fit completely under required lab coats or gowns. Appropriate closed-toe, closed-heel footwear is required at all times. Sandals, clogs, slippers, open-toe shoes, and open-heel shoes are prohibited. Makeup, nail polish, artificial nails, and scented personal products are not permitted in production areas. Jewelry and body piercings that may compromise gowning or gloves are prohibited. Any open wounds must be properly covered with bandages.