Operator I - Express

Equiliem
United States, Texas, Plano
Nov 13, 2025
Job Summary The Medical Device Assembler (Operator I) is responsible for assembling, repairing, and testing life-saving medical devices such as pacemakers, defibrillators (ICDs), and related components. This role requires precision, attention to detail, and adherence to strict FDA and Quality Management System standards. The assembler contributes to a safe and efficient manufacturing environment by maintaining accuracy in documentation, supporting continuous improvement initiatives, and collaborating effectively within a team. Job Responsibilities Assemble, repair, and test medical devices and components within a manufacturing cell Perform detailed work on small parts using hand tools and microscopes Follow standardized manufacturing procedures and quality guidelines to ensure compliance with FDA and Quality Management System requirements Maintain accurate production and quality documentation to ensure product traceability and safety Support continuous improvement initiatives to enhance manufacturing efficiency and product quality Communicate effectively with team members and maintain a positive, solutions-oriented approach Adhere to all safety and cleanroom protocols at all times Job Requirements High School Diploma or GED required Experience using hand tools required Strong attention to detail and ability to perform precise work on small components Ability to follow written procedures and verbal instructions accurately Basic computer and data entry skills Excellent time management and task prioritization abilities Team-oriented mindset with a willingness to learn and adapt in a fast-paced environment Work Experience Previous experience in manufacturing, assembly, or medical device production preferred but not required Additional Job Details (COVID, Commute, Attendance, etc.) Must be able to work on-site in a cleanroom environment, following all safety and hygiene protocols Consistent attendance and punctuality are essential to meet production and quality goals Adherence to all workplace health and safety policies, including any applicable infectious disease prevention measures, is required