Medical Device Assembler

4 weeks ago


West Jordan, Utah, United States Route 92 Medical Full time
Job Summary:

Route 92 Medical is seeking a skilled Medical Device Assembler to join our team. As a key member of our manufacturing operations, you will be responsible for assembling and testing medical devices, ensuring high-quality products that meet regulatory requirements.

Key Responsibilities:
  • Assemble and test medical devices according to Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
  • Train new hires and other coworkers on manufacturing procedures and equipment
  • Accurately document work on Lot History Record (LHR) and manufacturing forms
  • Set up and maintain workstations, adhering to CER requirements
  • Operate production equipment, including hot box, laminator, and coil winder
  • Perform visual inspections and use basic measuring tools, such as calipers and snap gauges
  • Identify non-conforming units and notify management
  • Provide feedback to management and engineers on process and product improvements
  • Problem-solve manufacturing-related issues
  • Maintain manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements

Requirements:
  • High school diploma or equivalent
  • Ability to read and speak English
  • Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements
  • Effective communication, interpersonal, and team skills
  • Excellent attention to detail and organization
  • Basic understanding of Lean Manufacturing concepts (Flow, 5S, Line Balance)

Preferred Experience:
  • Minimum of 5 years of experience in medical device manufacturing
  • Understanding of commonly used concepts, practices, and procedures within the medical device industry
  • Ability to use microscopes, tweezers, razor blades, pliers, and other handheld tools for small parts
  • Manufacturing device trainer
  • Proficiency with use of equipment, such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer


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