About the role: 

As a Manufacturing Technician you will produce cartridges and other tasks required within the manufacturing environment(s). To operate manufacturing and assembly equipment necessary for production within a clean room environment. To assemble and package various components used in making cartridge and kit assemblies. To follow, and review device manufacturing instruction, records, and work orders. To collect process data used to perform routine analysis for manager review.

Responsibilities: 

  • Follow cGMP and ISO standards or guidelines as they apply to manufacturing
  • Assemble cartridges and reagent kit components
  • Follow manufacturing SOPs
  • Organize and maintain floor area and supplies used during work performed
  • Work independently and as a part of an assembly line team
  • Maintain a safe work environment with respect to chemicals and equipment
  • Resolve line issues and suggest improvements
  • Operate all manufacturing line equipment.
  • Adhere to manufacturing schedule and complete manufacturing work orders in a timely manner
  • Review completed device manufacturing records and work orders, identify and correct errors, and submit finished documentation for quality release
  • Serve as a role model for cGMP manufacturing
  • Assist with special projects as requested and perform additional duties as assigned

 

Candidate requirements:

  • High School Diploma required; Bachelor’s Degree in an engineering or scientific field, FDA, cGMPs, and/or ISO knowledge a plus.
  • Minimum of two (2) years of experience working within a similar manufacturing environment and basic computer skill are required.
  • Strong experience with high vacuum chambers and assembly automation equipment is required.
  • Experience in working with printed circuit board inspection, assembly and packaging is required
  • Experience in working in a clean room environment under cGMP and ISO/FDA standards is required
  • Experience in manufacturing and assembling high quality medical devices is strongly preferred
  • Ability to handle delicate materials and do precision manual alignments during manufacturing
  • Ability to accurately and thoroughly document work on printed documents and computer databases
  • Ability to work according to assigned manufacturing schedule, ranging from an early morning to late afternoon shifts
  • Ability to be cross trained on all manufacturing processes with minimal training.
  • Provide recommendations for floor improvements
Job Overview
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