Production Assembly Technician

2 weeks ago


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

The Assembly Operator plays a crucial role in the manufacturing 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 Quality System Regulations (21 CFR 820) and ISO 13485 standards, ensuring compliance with the Quality Management System (QMS).

Key Responsibilities:
  • Interprets work orders, follows detailed production schematics, or acts on verbal instructions.
  • Completes all manufacturing processes post-training.
  • Accurately fills out essential documentation such as Lab Notebooks and Inspection Records.
  • Positions and aligns components in accordance with specified relationships in holding devices.
  • Conducts various assembly operations, including pad printing, adhesive bonding, and leak testing.
  • Modifies materials to meet specified requirements.
  • Executes testing and inspection to ensure production standards are met.
  • Packages completed assemblies for distribution.
  • Aims to meet daily production goals and quality standards.
Supervisor 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.
  • Capability to read and interpret technical documents.
  • Basic mathematical skills and proficiency in using measurement instruments.

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