Medical Device Assembler

Location: Irvine, CA
Shift:2nd 
• Work hours: 3:00PM to 11:30PM
• Word days: M-F
Pay Rate: $22HR

The Medical Device Assembler assembles, inspects, and packages medical devices in cleanroom and non-cleanroom environments. The position requires strict adherence to Good Manufacturing Practices (GMPs), written procedures, safety requirements, and Good Documentation Practices (GDPs).

• Assemble and package medical devices according to approved specifications, procedures, and GMP requirements.
• Rotate between assigned manufacturing operations and complete required training.
• Perform in-process quality inspections, including visual inspection of devices and packaging materials and airflow testing.
• Identify and immediately report product defects, process issues, and deviations to Leads or Supervisors.
• Accurately document manufacturing activities, data, and results according to GDP requirements.
• Clean and organize manufacturing equipment, tools, and supplies.
• Use proper PPE, including gowns, eye protection, face protection, shoe covers, and gloves.
• Follow cleanroom gowning procedures, including the use of sanitizer.
• Handle products, materials, and tools carefully to prevent damage and scrap.
• Work collaboratively with team members to maintain a productive and respectful work environment.
• Work on-site and complete all scheduled hours, including overtime when required.
• Follow all company safety instructions, procedures, and requirements.

• High school diploma, GED, or equivalent.
• Ability to read, write, and understand English.
• Ability to read and follow manufacturing procedures and written instructions.
• Ability to communicate effectively with Leads and Supervisors.
• Ability to pass a visual acuity test, including 20/20 corrected vision.
• Ability to pass Particulate Matter Certification.
• Strong attention to detail and manual dexterity.
• Previous medical device, manufacturing, cleanroom, assembly, or packaging experience is preferred but not required.

• Perform repetitive movements involving the hands, wrists, and fingers.
• Use close visual acuity for inspecting small parts, defects, packaging, and assembled devices.
• Distinguish color, depth, and field of vision.
• Sit, stand, walk, reach, and perform detailed assembly tasks as required.
• Exert up to 10 pounds of force occasionally and minimal force frequently.
• Communicate and hear at normal speaking levels; some areas may require speaking above ambient noise.
• Work near moving equipment, vehicles, electrical current, chemicals, and other manufacturing-related hazards while following all safety procedures.
• Wear required cleanroom garments and PPE for extended periods.