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Manufacturing Assembly Technician

2 months ago

San Jose, California, United States CathX Medical Full time

JOB SUMMARY
Assembly Operators play a crucial role in the production of medical components, subassemblies, products, or systems. Each team member is expected to uphold cleanliness and organization within the workspace while adhering to CathX Medical's policies and procedures. This position complies with FDA QSR (21 CFR 820) and ISO 13485 standards, ensuring alignment with the Quality Management System (QMS).

KEY RESPONSIBILITIES:

  • Interpret work orders, follow production schematics, and receive verbal instructions regarding tasks to be completed.
  • Demonstrate proficiency in all manufacturing procedures following training.
  • Accurately complete essential documentation, including Lab Notebooks, Device Master Records (DMR's), Lot History Records (LHR's), Inspection Records, and Validation Documentation.
  • Position and align components according to specified relationships using jigs, fixtures, or other holding devices.
  • Execute various joining techniques such as crimping, staking, screwing, bolting, riveting, welding, soldering, cementing, and press fitting.
  • Carry out intermediate assembly tasks, including pad printing, adhesive bonding, hot air bonding, balloon bonding, wire etching, shaft swaging, skiving, folding, marking, braiding, coiling, and leak testing.
  • Adjust and trim materials from components to meet specified medical or dimensional criteria.
  • Conduct online go/no-go testing and inspections to verify that parts and assemblies conform to production specifications and standards.
  • Package completed assemblies or subassemblies in clear plastic bags.
  • Achieve daily production goals and standards.

SUPERVISORY ROLE:
This position does not entail any supervisory responsibilities.

REQUIREMENTS:

  • High School Diploma or equivalent experience in the medical device sector.
  • Familiarity with Good Manufacturing Practices and Good Documentation Practices.
  • Ability to read and interpret safety regulations, operational and maintenance instructions, and procedural manuals.
  • Proficient in basic mathematical calculations (i.e., decimals, addition, subtraction, multiplication, and division).
  • Competence in using measurement tools such as microscopes and pin gauges, and comparing measurements to established standards.

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