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Assembly Technician

2 months ago

San Jose, California, United States CathX Medical Full time
Job Overview

CathX Medical is seeking a skilled Assembly Technician to join our team in the assembly of medical components, subassemblies, products, or systems. As an Assembly Technician, you will be responsible for maintaining a clean and organized work area, adhering to company policies and procedures, and complying with FDA QSR (21 CFR 820) and ISO 13485 requirements.

Key Responsibilities
  • Read and follow work orders, production drawings, and sample assemblies to perform assembly tasks.
  • Ability to perform and demonstrate all manufacturing procedures after training.
  • Accurately complete all essential documents, including lab notebooks, device master records, lot history records, inspection records, and validation documentation.
  • Position and align parts in specified relationships to each other in jig, fixture, or other holding devices.
  • Crimp, stake, screw, bolt, rivet, weld, solder, cement, press fit, or perform similar operations to join or secure parts in place.
  • Perform intermediate assembly tasks, such as pad printing, adhesive bonding, hot air bonding, balloon bonding, etching wires, swaging shafts, fusing skiving shafts, folding, marking, braiding, coiling, and perform leak testing.
  • Adjust and trim materials from components to achieve specified medical or dimensional characteristics.
  • Perform online go-not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
  • Packages finished assemblies or subassemblies in clear plastic bags.
Requirements
  • High School Diploma or equivalent work experience in the medical device industry.
  • Knowledge of Good Manufacturing Process and Good Documentation Practice.
  • Ability to read and interpret documents, such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Must have the ability to calculate figures and amounts using basic math (i.e., decimals, addition, subtraction, multiplication, and division).
  • Ability to use measurement tools, like microscopes and pin gauges, and to compare measurements to documented standards.