Operator I

Job Title: Medical Device Assembler (Non-Exempt) Schedule: Monday Thursday, 6:00 AM 4:30 PM Location: Plano, TX Position Overview: We are seeking a detail-oriented and safety-conscious Medical Device Assembler to join our manufacturing team. This role is responsible for producing high-quality medical devices, including pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies, within a manufacturing cell. The position requires following strict procedures, maintaining accurate records, and ensuring compliance with quality, safety, and regulatory standards. Key Responsibilities: Assemble, repair, and test medical devices according to standardized procedures. Follow work instructions, ensuring accuracy in all documentation and traveler records. Perform tasks under close supervision with continual review to ensure compliance and quality. Communicate clearly with team members, supervisors, and management to report issues and propose solutions. Participate in continuous improvement and Lean Manufacturing initiatives to enhance productivity and quality. Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Maintain a clean, organized, and compliant work environment at all times. Qualifications: Required: High school diploma or equivalent. Minimum of [X months/years] manufacturing experience (medical device experience preferred). Ability to read, comprehend, and follow written and verbal instructions. Skilled in handling and maneuvering small components and parts. Capable of making sound decisions with minimal supervision. Familiarity with electronic data collection systems and computer software. Ability to prioritize tasks based on sequence, importance, and deadlines. Physical & Compliance Requirements: Adherence to strict dress code to prevent contamination: Sweaters, fleece, or loose-knit garments are prohibited in production areas. Clothing must be non-shedding, free of loose fibers, threads, or decorative elements that could dislodge. All clothing from the waist up must fit under the lab coat/gown with no protruding sleeves, necklines, or hems Shoes must be closed-toe, closed-heel, and flat or low-heeled (max 2 inches). Sandals, clogs, or footwear with openings are not allowed. Jewelry, artificial nails, nail polish, and makeup (except plain stick lip balm applied before handwashing) are prohibited in production areas. Scented products are not permitted, except unscented deodorant. Must follow all gowning, safety, and hygiene protocols. Work Environment: Manufacturing cell environment with close supervision and high attention to detail. Position may require extended periods of sitting or standing and handling small tools/components.

Created: 2025-09-24