Responsibilities and Authority

  • Performs testing and troubleshooting on subassemblies, final assemblies, and finished medical devices per written specifications e.g., customer specified testing instructions, test records, etc.
  • May assist in development of advanced testing methodologies and procedures.
  • Testing includes:
    • Electrical Safety Testing (HiPot, Ground Bond, Leakage testing)
    • Pressure and Leak testing
    • Near and Far Field Laser alignment and testing
    • Advanced optical alignment using aiming beams, oscilloscopes, etc.
    • Laser radiation characterization using energy and power meters, interferometers, beam profilers, and other tools.
    • Optical sub-assembly testing
    • Performance verification using both automated and GUI test software
    • Functional testing at component, subassembly, and finished goods level
    • Electronic system troubleshooting using various tools, including but not limited to DVM, Ammeter, Oscilloscope
  • Recording and logging Test data using Word, Excel, LabView, StarLab, MiniTab
  • Other testing and troubleshooting as required.
  • Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485:2016 requirements.
  • Understands and follows good documentation practices in a cGMP and ISO 13485:2016 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 degree in engineering discipline or course work in electronics, physics, and/or optics very beneficial.
  • Previous work experience in medical device manufacturing a plus.
  • Five years minimum experience in electro-mechanical / electro-optical testing required.
  • 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, required.
  • Familiarity with opto-mechanical tools and equipment in an optical/laser lab setting.
  • Experience in optical components handling; familiarity with optics cleaning tools and methods
  • Familiarity with clean room procedures
  • 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 advanced 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
    • Ability to pass eye exam enabling work with laser systems