Performs testing on sub assemblies, 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, Oscilloscope


• Recording and logging Test data using Word, Excel, LabView, StarLab


• Responsible for following company 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.