Manufacturing Assembler

1 week ago


Sunnyvale, California, United States CathX Medical Full time
Position Summary

The Assembly Operator plays a crucial role in the production of medical components and systems. Team members are expected to maintain a clean and organized workspace while adhering to the policies set forth by CathX Medical. This position is aligned with FDA QSR (21 CFR 820) and ISO 13485 standards, ensuring compliance with the Quality Management System (QMS).

Key Responsibilities:
  • Interprets work orders, follows production schematics, or takes verbal guidance.
  • Executes all manufacturing protocols post-training.
  • Accurately completes essential documentation, including Lab Notebooks and Inspection Records.
  • Positions and aligns components in designated fixtures.
  • Conducts various assembly operations, including pad printing, adhesive application, and leak assessments.
  • Modifies materials to meet specified criteria.
  • Performs testing and inspections to ensure adherence to production standards.
  • Packages completed assemblies for distribution.
  • Aims to meet daily production targets and quality benchmarks.
Supervisory Duties:

This role does not entail any supervisory responsibilities.

Required Qualifications:
  • High School Diploma or equivalent experience in the medical device sector.
  • Familiarity with Good Manufacturing Practices and Good Documentation Practices.
  • Ability to read and understand technical documents.
  • Basic mathematical skills and proficiency with measurement instruments.


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