Operator I

Operator, 1st Shift

This position is responsible for producing high-quality medical devices within a manufacturing cell. Working under close supervision, the individual may perform a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter-defibrillators (ICDs), leads, and related medical device assemblies. The role involves performing routine assignments in accordance with established procedures and standardized work instructions. Work is closely reviewed to ensure compliance with quality, safety, and manufacturing requirements.

Key responsibilities include performing assembly, repair, testing, and related manufacturing operations on medical device products and components. Follow established written procedures, standardized work instructions, and verbal directions. Ensure all job documentation and cell-related procedures are accurate and up to date. Maintain accurate production and quality records, including traveler and quality documentation. Ensure all parts and components are properly traceable and that quality issues can be identified and addressed. Communicate ideas, problems, and solutions clearly and effectively to all levels of manufacturing management, both verbally and in writing. Maintain a positive and professional attitude when interacting with internal customers and external visitors, including facility tours. Follow all safety guidelines and use appropriate safety equipment and devices during operations. Participate in continuous improvement and quality initiatives designed to improve production processes, product quality, and profitability. Demonstrate a basic understanding of Lean Manufacturing principles. Work with the Manufacturing Supervisor/Manager to establish and monitor individual goals and cell performance metrics. Continuously seek opportunities to improve the quality and efficiency of manufacturing operations. Support divisional initiatives and comply with requirements related to the Quality Management System (QMS), Environmental Management System (EMS), and other applicable regulatory requirements.

Required skills and qualifications include the ability to read, understand, and follow written procedures and verbal instructions. Ability to use electronic data collection systems and standard computer software. Ability to prioritize work and determine the appropriate sequence and timing of tasks based on precedence and importance. Ability to handle and maneuver small components and parts with care and precision. Ability to make critical decisions and sound judgments with minimal supervision. Ability to work effectively in a highly regulated manufacturing environment. Strong attention to detail and commitment to product quality. High school diploma or equivalent required. Production Area Dress & Safety Requirements