Cogmedix

The Laser Optics Test Technician will perform advanced optical alignment using aiming beams, oscilloscopes, etc on a variety of significantly complex electro-mechanical and optically based assemblies and finished medical devices. Must have a high level of detail and understanding of  Current Good Manufacturing Practices (cGMP).  The Laser Optical Test Technician will ensure safe test practices are followed and will escalate whenever they are uncertain. The Laser Optics Test Technician will use a variety of tools and test methods and adhere to properly released work instructions and Quality System procedures, proper material handling, ESD procedures, and more. All Laser Optics Test Technicians are also responsible for following good documentation practices (GDP) and performing all required electronic systems transactions accurately and in real time.  Laser Optics Test Technicians may be part of a Scaled Product Launch™ Team, work directly with customers, may train other Test Technicians, and may perform advanced level troubleshooting of components, sub-assemblies, or finished systems.

Responsibilities:

    1. Performs laser radiation characterization using energy and power meters, interferometers, beam profilers and other alignment tools.  Will also perform testing and troubleshooting on subassemblies, final assemblies, and finished medical devices per written specifications e.g., customer specified testing instructions, test records, etc. 
    2. May assist in development of advanced testing methodologies and procedures.
    3. Testing includes:
      1. Electrical Safety Testing (HiPot, Ground Bond, Leakage testing).
      2. Pressure and Leak testing.
      3. Near and Far Field Laser alignment and testing.
      4. Advanced optical alignment using aiming beams, oscilloscopes, etc.
      5. Laser radiation characterization using energy and power meters, interferometers, beam profilers, and other tools. 
      6. Optical sub-assembly testing.
      7. Performance verification using both automated and GUI test software.
      8. Functional testing at component, subassembly, and finished goods level.
      9. Electronic system troubleshooting using various tools, including but not limited to DVM, Ammeter, and Oscilloscope.
      10. Recording and logging Test data using Word, Excel, LabVIEW, StarLab, MiniTab.
      11. Other testing and troubleshooting as required.
    4. Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485 requirements.
    5. Understands and follows good documentation practices in a cGMP and ISO 13485 environment.
    6. Maintains manufacturing documentation as outlined in the work order package and defined by the customer.  
    7. Identifies and reports any product quality problems or discrepancies.  
    8. Documents non-conformances. 
    9. Maintains the work area and equipment in a clean and orderly condition and follows prescribed safety regulations.  
    10. Maintains proper control of device traceability, materials and non-conforming material.  
    11. May train other Test Technicians.
    12. Performs other activities as directed.

Essential Requirements

    1. Consistently collimates and aligns lasers and is well versed on the safe handling of circuitry and optics.
    2. Positive attitude, self-motivator, tenacious follow up, and superior organization skills.
    3. Superior customer service attitude.
    4. Excellent teamwork, communication and interpersonal skills.  
    5. High school diploma or equivalent required. College degree in engineering discipline or course work in electronics, physics, and/or optics very beneficial.
    6. Previous work experience in medical device manufacturing a plus.
    7. Five years minimum experience in electro-mechanical / electro-optical testing required.
    8. Experience in a high-mix product manufacturing environment required.
    9. Must be able to read, write, and understand concepts and detailed instructions, test procedures, and records in English.   
    10. Familiarity with hi-pot testing, ground bond testing, electrical safety testing, use of DMM, required.
    11.  Familiarity with opto-mechanical tools and equipment in an optical/laser lab setting required.
    12.  Experience in optical components handling; familiarity with optics cleaning tools and methods.
    13.  Familiarity with clean room procedures.
    14.  Working knowledge of computers, including Microsoft Office (Word and Excel) and ability to load software and manage different test applications.  
    15.  Very detail oriented, strong commitment to quality and a high degree of accuracy.  
    16.  Able to understand advanced manufacturing methods.
    17.  A demonstrated commitment to company values.
    18.  Excellent manual dexterity and eye/hand coordination.
    19.  Standing for prolonged periods of time.
    20.  Sitting for prolonged periods of time.
    21.  Ability to lift up to 30 lbs.
    22.  Ability to pass eye exam enabling work with laser systems.