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 a variety of assembly, repair, and testing tasks related to medical catheters. The Operator I ensures compliance with all quality standards and regulatory requirements while maintaining accurate documentation and following established safety procedures. Effective communication, attention to detail, and a positive attitude are essential to success in this position. Job Responsibilities Assemble, repair, and test medical catheters according to standardized procedures. Maintain compliance with quality, safety, and regulatory standards in all operations. Accurately document all production activities to ensure full traceability and compliance with FDA requirements. Communicate clearly with supervisors and team members regarding ideas, issues, and process improvements. Handle and assemble small components and parts using microscopes and precision tools. Maintain a clean, organized workspace and follow cleanroom protocols. Exhibit a positive, professional attitude when working with internal and external stakeholders. Support production goals and contribute to continuous improvement initiatives. Job Requirements Ability to read, comprehend, and follow written procedures and verbal instructions. Strong attention to detail with a focus on quality and accuracy. Manual dexterity and ability to manipulate small components with precision. Ability to sit or stand for extended periods and perform repetitive hand movements such as grabbing, pinching, pulling, and twisting. Basic computer skills for maintaining written and electronic documentation. Education High school diploma or equivalent required. Work Experience Prior experience in medical device assembly or cleanroom manufacturing preferred. Experience working with microscopes, performing manual assembly, and hand soldering desirable. Additional Job Details Must comply with all FDA regulations, quality standards, and safety procedures. Cleanroom gowning and adherence to contamination control protocols are required. Accurate and timely documentation is essential for ensuring product traceability and addressing quality issues.