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Medical Assembly Technician

2 months ago

San Jose, California, United States CathX Medical Full time

JOB SUMMARY
Assembly Technicians play a crucial role in the production of medical components, subassemblies, and systems. Each team member is tasked with upholding cleanliness and organization within the workspace while adhering to CathX Medical's established policies and procedures. This position is compliant 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 to execute assigned tasks effectively.
  • Demonstrate proficiency in all manufacturing processes post-training.
  • Accurately complete essential documentation, including Lab Notebooks, Device Master Records (DMRs), Lot History Records (LHRs), 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.
  • Conduct intermediate assembly tasks, including pad printing, adhesive bonding, hot air bonding, etching wires, and performing leak tests.
  • Adjust and trim materials to meet specified medical or dimensional criteria.
  • Perform online go/no-go testing and inspections to verify that parts and assemblies conform to production specifications.
  • Package completed assemblies or subassemblies in transparent plastic bags.
  • Achieve daily production goals and standards.

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

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 guidelines, operational instructions, and procedural manuals.
  • Proficient in basic mathematics, including decimals, addition, subtraction, multiplication, and division.
  • Competence in using measurement tools such as microscopes and pin gauges, with the ability to compare measurements against documented standards.

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