Operator/ Machine Operator/ Assembler/ Cleanroom

Operator I 2nd Shift
Location: Irvine, California
Shift: 2nd Shift, 3:00 PM 11:30 PM
Work Environment: Onsite | Cleanroom | Medical Device Manufacturing Job Summary:
The Operator I is responsible for producing high-quality medical devices in a regulated manufacturing and cleanroom environment. Working under close supervision, the Operator I performs routine assembly, repair, testing, and manufacturing operations on medical catheters and related medical device assemblies.

The position requires strong attention to detail, the ability to follow standardized procedures, and the ability to work with small components and parts using hand tools and microscope-based assembly techniques.

Key Responsibilities:

• Perform manual assembly, repair, testing, and inspection of medical devices and components.
• Work with medical catheters and related medical device assemblies according to established procedures.
• Follow standard operating procedures (SOPs), work instructions, manufacturing procedures, and verbal instructions.
• Maintain compliance with FDA, GMP, quality, and safety requirements.
• Perform repetitive manufacturing tasks while maintaining consistent quality and productivity.
• Handle and maneuver small components and parts under a microscope.
• Use hand tools and manufacturing equipment as required.
• Perform tasks involving grabbing, pinching, pulling, twisting, and fine motor movements.
• Maintain accurate written and electronic manufacturing documentation and records.
• Ensure product and component traceability throughout the manufacturing process.
• Identify and communicate quality issues, problems, and potential process concerns.
• Clearly communicate ideas, problems, and solutions to team members and supervisors.
• Maintain a positive and professional attitude when interacting with internal and external customers.
• Follow all cleanroom, safety, gowning, contamination-control, and workplace procedures.
• Maintain a clean and organized manufacturing work area.
• Perform routine assignments under close supervision and according to standardized procedures.

Preferred Experience:

• Experience with medical device manufacturing or assembly.
• Manual assembly of medical devices.
• Experience assembling small components under a microscope.
• Experience working in a cleanroom environment.
• Experience with hand soldering.
• Experience using hand tools for precision assembly.
• Experience maintaining written and electronic documentation.
• Manufacturing, production, assembly, or electronics experience is a plus.