• Performs testing on subassemblies, final assemblies, and finished medical devices per written specifications e.g., customer specified testing instructions, test records, etc.
      • Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485:2003 requirements.
      • Understands and follows good documentation practices in a cGMP and ISO 13485:2003 environment.
      • Maintains manufacturing documentation as outlined in the work order package and defined by the customer.
      • Identifies and reports any product quality problems or discrepancies.
      • Documents non-conformances.
      • Maintains the work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
      • Maintains proper control of device traceability, materials and non-conforming material.
      • Performs other activities as directed.

Essential Requirements

    • Positive attitude, self-motivator, tenacious follow up, and superior organization skills.
    • Superior customer service attitude.
    • Excellent teamwork, communication and interpersonal skills.
    • High school diploma or equivalent required. College work or degree a plus.
    • Previous work experience in medical device manufacturing a plus.
    • 2 years minimum experience in electro-mechanical testing preferred.
    • Must be able to read, write, and understand concepts and detailed instructions, test procedures, and records in English.
    • Familiarity with hi-pot testing, ground bond testing, electrical safety testing, use of DMM, etc.
    • Working knowledge of computers, including Microsoft Office (Word and Excel) and ability to load software and manage different test applications.
    • Very detail oriented, strong commitment to quality and a high degree of accuracy.
    • Able to understand basic manufacturing methods.
    • A demonstrated commitment to company values.

Physical Requirements

  • Excellent manual dexterity and eye/hand coordination
  • Standing for prolonged periods of time
  • Sitting for prolonged periods of time
  • Ability to lift up to 30 lbs