Medical Device Assembler

Job Title: Medical Device Assembler Location: Westfield, IN Shift: 6:00 AM - 2:30 PM Job Summary The Operator I is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, this role performs assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components. All tasks are performed in accordance with standardized procedures, quality requirements, and regulatory standards. Key Responsibilities ssemble, repair, and test medical device components following documented procedures. Perform routine assignments with close supervision and ongoing review. Maintain accurate and up-to-date production and quality documentation to ensure full product traceability. Utilize electronic data collection systems and relevant computer software. Conduct visual inspections and ensure product quality standards are met. Communicate effectively with manufacturing management regarding issues, ideas, and solutions. Follow all safety guidelines and use appropriate protective equipment. Support continuous improvement and Lean Manufacturing initiatives. ssist in monitoring individual and team performance metrics. Ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Prioritize tasks based on production needs and deadlines. Handle small components requiring precision and manual dexterity. Qualifications High School Diploma or equivalent required. bility to read, comprehend, and follow written and verbal instructions. Basic understanding of Lean Manufacturing principles. Strong attention to detail and quality standards. bility to make sound decisions with minimal supervision. Comfortable working in a controlled manufacturing or cleanroom environment. Dress Code Requirements Clothing must be non-shedding, clean, and free of loose fibers, frays, glitter, sequins, or embellishments. Sweaters, fleece, loose knit garments, or fiber-shedding materials are not permitted. Clothing must fit under lab coats/gowns; sleeves and collars must not extend beyond gown coverage. Closed-toe shoes required (heel no higher than 2 inches); no sandals, open-toe, or open-heel shoes. Pants must extend to the ankle; no sleeveless tops, short shirts, or clothing above the ankle. No nail polish, artificial nails, jewelry, visible piercings, or makeup. No scented products (except deodorant). ll safety and gowning procedures must be followed at all times.

Created: 2026-03-04