Operator I - 2nd Shift

Equiliem
United States, California, Irvine
Oct 06, 2025
Job Summary The Operator I is a non-exempt position responsible for producing high-quality medical devices in a cleanroom environment. Working under close supervision, this role performs assembly, repair, and testing of medical catheters while adhering to strict quality and compliance standards. The Operator I is expected to maintain accurate documentation, follow established safety and FDA guidelines, and communicate effectively with team members and supervisors. Job Responsibilities Perform assembly, repair, and testing operations on medical catheters according to standardized procedures. Maintain compliance with quality and safety standards while performing routine tasks. Accurately complete all required documentation to ensure full traceability and regulatory compliance. Communicate clearly with supervisors and team members regarding issues, ideas, and solutions. Handle and manipulate small components and parts under a microscope. Follow all safety guidelines and maintain a clean, organized workspace. Demonstrate a positive and professional attitude when interacting with internal and external stakeholders. Support continuous improvement and adherence to established production schedules. Job Requirements Ability to read, comprehend, and follow written and verbal instructions. Strong attention to detail and commitment to product quality. Manual dexterity to handle and assemble small components using fine motor skills. Ability to sit or stand for long periods and perform repetitive hand motions such as grabbing, pinching, pulling, and twisting. Basic computer literacy for maintaining written and electronic documentation. Education High school diploma or equivalent required. Work Experience Experience in medical device assembly or a cleanroom manufacturing environment preferred. Prior experience using microscopes, performing manual assembly, and hand soldering is desirable. Additional Job Details Must comply with all FDA, safety, and quality control standards. Cleanroom gowning and adherence to contamination control procedures are required. Accurate documentation is essential to ensure traceability and address potential quality issues.