Manufacturing ​/ Production Operator, Manufacturing Production

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.

• 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

• 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

• Shift: Monday–Thursday, 6:00 AM–4:30 PM
• Location: Plano, Texas
• Full-time, on-site position

To ensure product safety and compliance within the cleanroom environment, all employees must adhere to the following attire and appearance 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

• 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

• 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

• 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

• 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

• 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