Job Description

The Operator I role is responsible for supporting the production of high-quality medical devices in a manufacturing environment. Under close supervision, candidates will perform assembly, repair, and testing operations on pacemakers, ICDs, leads, and related medical device components while following standardized procedures and quality guidelines.

• Assemble, repair, and test medical device components
• Follow detailed written and verbal work instructions
• Maintain accurate production and quality records
• Support Lean Manufacturing and continuous improvement initiatives
• Ensure compliance with Quality Management Systems (QMS) and safety procedures
• Communicate effectively with supervisors and team members
• Handle small components with precision and attention to detail
• Utilize electronic data collection systems and computer software

• High school diploma or equivalent
• Ability to read, understand, and follow procedures and instructions
• Basic computer skills and electronic documentation experience
• Strong attention to detail and ability to work in a regulated manufacturing environment
• Ability to prioritize tasks and work with minimal supervision
• Good manual dexterity for handling small parts/components

• Medical device manufacturing environment with strict cleanroom/gowning requirements
• Candidates must follow detailed dress code, hygiene, and contamination-control standards
• PPE and production-area compliance required at all times

• Medical device manufacturing experience
• Assembly or production line experience
• Knowledge of Lean Manufacturing principles
• Experience in regulated environments (FDA/GMP)

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