The Test Technician will perform test and troubleshooting processes on a variety of significantly complex electro-mechanical and optically based sub-assemblies and finished medical devices while following Current Good Manufacturing Practices (cGMP). The Test Technician will ensure safe test practices are followed and will escalate whenever they are uncertain. The 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 Test Technicians are also responsible for following good documentation practices (GDP) and performing all required electronic systems transactions accurately and in real time.
- Performs testing on subassemblies, final assemblies, and finished medical devices per written specifications e.g., customer specified testing instructions, test records, etc.
- Testing may include:
- Electrical Safety Testing (HiPot, Ground Bond, Leakage testing).
- Pressure and Leak testing.
- Near and Far Field Laser alignment and testing.
- Optical alignment.
- Optical sub-assembly testing.
- Performance verification using both automated and GUI test software.
- Functional testing at subassembly and finished goods level.
- Troubleshooting using various tools, including but not limited to DVM, Ammeter, and Oscilloscope.
- Recording and logging Test data using Word, Excel, LabVIEW, StarLab.
- Performs other tests and troubleshooting as required.
- Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO 13485 requirements.
- Understands and follows good documentation practices in a cGMP and ISO 13485 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.
- 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., is beneficial.
- Working knowledge of computers, including Microsoft Office (Word and Excel) and ability to load software and manage different test applications required.
- 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.
- 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.