Job Title: Operator I 2nd Shift Location:Irvine, CA Shift:2nd Shift | 3:00 PM 11:30 PMJob Description: We are seeking a detail-oriented Operator I to join our medical device manufacturing team in a cleanroom environment. This role is responsible for assembling, testing, inspecting, and repairing high-quality medical devices while following FDA regulations, quality standards, and standardized manufacturing procedures. Responsibilities:
Assemble medical devices, catheters, pacemakers, ICDs, leads, and related components.
Perform assembly, inspection, testing, and repair of medical device products.
Handle small components using microscopes and precision tools.
Perform manual assembly in a cleanroom manufacturing environment.
Use hand tools and perform hand soldering when required.
Complete accurate written and electronic production documentation.
Follow Standard Operating Procedures (SOPs), GMP, FDA, and quality requirements.
Maintain traceability and documentation for all products.
Inspect products to ensure they meet quality specifications.
Communicate production issues and recommend solutions to supervisors.
Maintain a clean, safe, and organized work environment.
Follow all company safety policies and cleanroom gowning requirements.
Support production goals while maintaining high-quality standards.
Required Qualifications:
High School Diploma or GED.
Previous manufacturing or assembly experience preferred.
Experience working in a cleanroom environment is a plus.
Ability to work with small components under a microscope.
Experience with manual assembly and precision hand tools.
Hand soldering experience preferred.
Strong attention to detail and manual dexterity.
Ability to read and follow written work instructions.
Basic computer and documentation skills.
Good verbal and written communication skills.
Ability to sit or stand for extended periods.
Ability to perform repetitive hand movements including grabbing, pinching, pulling, and twisting.
Preferred Experience:
Medical device manufacturing.
Catheter assembly.
Pacemaker or ICD assembly.
Cleanroom manufacturing.
Microscope inspection and assembly.
Hand soldering.
FDA, GMP, and ISO regulated manufacturing.
Numbers & Facts
Location
Irvine, CA
Skills
Catheterizationunmatched
Cleanroomunmatched
Communication Skillsunmatched
Detail Orientedunmatched
Documentationunmatched
Electronics Manufacturingunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Hand Toolsunmatched
Healthcare Qualityunmatched
High School Diplomaunmatched
ISO (International Organization for Standardization)unmatched
International Classification of Diseases (ICD)unmatched
Manual Dexterityunmatched
Manufacturingunmatched
Manufacturing Assemblyunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Organizational Skillsunmatched
Pacemakerunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Documentationunmatched
Production Supportunmatched
Quality Managementunmatched
Quality Metricsunmatched
Safety/Work Safetyunmatched
Solderingunmatched
Standard Operating Procedures (SOP)unmatched
Testingunmatched
Traceabilityunmatched
Writing Skillsunmatched
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