Production Operator I

Schedule:
Monday–Thursday, 4:00 AM – 2:30 PM

Position Summary
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the Manufacturing Associate performs a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Assignments are routine and completed according to established procedures and standards, with work closely monitored and reviewed.

Key Responsibilities

• Assemble, repair, and test medical device components and assemblies according to documented procedures and quality standards.
• Maintain accurate and up-to-date job documentation for manufacturing cell operations and functions.
• Communicate ideas, issues, and solutions effectively to all levels of manufacturing management, both verbally and in writing.
• Maintain a professional and positive attitude when interacting with internal teams and external visitors, including facility tours.
• Follow all safety guidelines and use appropriate personal protective equipment (PPE) and safety devices during operations.
• Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and productivity goals.
• Maintain accurate production records to ensure traceability of parts, completion of traveler documentation, and resolution of quality concerns.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Collaborate with Manufacturing Supervisors and Managers to establish and monitor individual performance goals and cell metrics focused on continuous improvement.
• Support divisional initiatives and comply with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.

Qualifications

• Ability to read, understand, and follow written procedures and verbal instructions.
• Basic understanding of electronic data collection systems and computer software applications.
• Strong organizational skills with the ability to prioritize work and manage multiple tasks based on urgency and importance.
• Ability to handle and manipulate small components and parts with precision.
• Ability to make sound decisions and exercise good judgment with minimal supervision.
• High school diploma or equivalent preferred.