Operator I

Equiliem
United States, Texas, Plano
Oct 08, 2025
Position Overview We are seeking a detail-oriented and safety-conscious Medical Device Production Operator to join our manufacturing team in Plano, Texas. This position is responsible for producing high-quality medical devices-including pacemakers, implantable cardioverter defibrillators (ICDs), and related assemblies-within a controlled manufacturing cell. Working under close supervision, the operator performs assembly, repair, and testing operations while maintaining compliance with all safety, quality, and regulatory standards. Job Responsibilities Perform assembly, testing, and repair of medical device components according to established procedures and work instructions Ensure all job documentation related to cell operations is accurate and up to date Maintain complete and accurate traveler and quality records to ensure product traceability and compliance Communicate clearly and professionally with team members and management regarding ideas, problems, and solutions Follow all safety guidelines and utilize required protective equipment when performing operations Participate in continuous improvement and Lean Manufacturing initiatives to enhance production efficiency and quality Support the Manufacturing Supervisor/Manager in monitoring and achieving production and quality metrics Handle and assemble small, delicate components with precision and care Comply with all requirements of the Quality Management System (QMS), Environmental Management System (EMS), and related regulatory standards Maintain a clean, organized, and compliant work environment Job Requirements High school diploma or equivalent required Ability to read, understand, and follow written and verbal instructions Familiarity with electronic data collection systems and computer software programs Strong attention to detail and organizational skills Ability to prioritize tasks and manage workflow to meet production deadlines Manual dexterity and ability to handle small components safely and accurately Capable of making sound decisions with minimal supervision Demonstrated commitment to safety, quality, and teamwork Schedule Shift: Monday-Thursday, 6:00 AM-4:30 PM Location: Plano, Texas Full-time, on-site position Dress Code Requirements To ensure product safety and compliance within the cleanroom environment, all employees must adhere to the following attire and appearance guidelines: General Guidelines: Clothing must be non-shedding, clean, and free of frayed hems, loose threads, glitter, sequins, or decorative attachments Sweaters, fleece, and loose-knit garments are not permitted All upper-body clothing must fit completely under the lab coat/gown Sleeves and collars may not extend beyond gown cuffs or neckline Headwear: Bouffant must fully cover hair; no hats, scarves, or bandanas may be worn underneath Customary head coverings (for religious or cultural purposes) must be clean, tightly woven, fully covered by a bouffant, and contained within the gown Footwear: Closed-toe, closed-heel shoes with heels under 2 inches are required Sandals, clogs, slippers, or open-toe/heel shoes are not allowed Socks or stockings must be worn at all times Personal Appearance: No nail polish, acrylic, or artificial nails permitted Jewelry, piercings, and accessories that could pierce gloves or interfere with gowning are prohibited No makeup, scented products, or lotions applied after handwashing Cover any open or bleeding wounds with a bandage before entering production areas Physical Requirements Ability to stand, sit, and perform repetitive hand motions for extended periods Manual dexterity for handling and assembling small parts Must adhere to gowning and cleanroom protocols throughout the shift Additional Job Details All work must comply with company safety, quality, and regulatory policies Participation in training, audits, and process improvement initiatives may be required Must maintain punctuality and reliability in attendance