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Job Summary
The Operator I is a non-exempt position responsible for the production of high-quality medical devices within a cleanroom environment. Working under close supervision, this role performs a combination of assembly, repair, and testing operations on medical catheters while maintaining compliance with established procedures and quality standards. The Operator I is expected to communicate effectively, maintain accurate documentation, and adhere to all safety and regulatory requirements. Job Responsibilities
Perform assembly, repair, and testing of medical catheters in a cleanroom environment.
Follow standardized work instructions, procedures, and quality guidelines.
Maintain accurate and complete production documentation to ensure traceability and compliance with FDA regulations.
Communicate clearly with supervisors, peers, and other departments regarding production issues, ideas, and improvements.
Operate and handle small components and tools under a microscope.
Follow all safety policies and maintain a clean, organized workspace.
Support continuous improvement initiatives and maintain a positive, professional attitude.
Job Requirements
Ability to read, comprehend, and follow written and verbal instructions.
Manual dexterity to handle, assemble, and inspect small parts using fine motor skills.
Ability to sit or stand for extended periods and perform repetitive hand movements such as grabbing, pinching, pulling, and twisting.
Attention to detail and commitment to producing high-quality work.
Basic computer skills for maintaining electronic documentation.
Education
Work Experience
Prior experience in medical device assembly, cleanroom operations, or a related manufacturing environment preferred.
Experience with manual assembly, microscope-based work, and hand soldering is desirable.
Additional Job Details
Must comply with all company safety and quality standards.
Cleanroom attire and adherence to contamination control procedures are required.
Accurate documentation is essential to meet FDA traceability and quality requirements.
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Equiliem
Oct 06, 2025