Background that includes at least 5 years experience in testing and/or repairing electronic devices. Prefer experience working in a medical device company. Assemble and test product development prototypes. Create test plans and test reports in compliance with various regulations according to internal and FDA requirements. Repairs customer returned product.
Major Roles and Responsibilities:
- Build prototype models by identifying or fabricating parts, assemble electronic circuits, and perform mechanical assembly
- Troubleshoot prototype functional problems and perform or recommend modifications. Apply principles and theories of electronics and mathematics to effectively debug and correct operational or performance problems with prototypes or finished product.
- Perform verification and validation testing and document results by generating formal test reports
- Ensures test equipment is calibrated and maintains logs
- Troubleshoot product as required that has been returned for repair. Identify functional problems at the system, subsystem or component level and document using approved procedures. Communicate product issues to Engineering and Manufacturing as input for product improvements
- Perform regulatory tests for prototype products
Job Requirements
- Associates Degree or equivalent technical training. 5 + years of related experience.
- Experience in an FDA regulated environment.
- Experience in creating and executing design verification test plans and performing verification and validation testing
- Knowledgeable with the use of most test equipment including oscilloscopes, data logging equipment, and logic analyzers
- Electronic and mechanical assembly experience
- Product assembly experience including component soldering
- Proficiency in Microsoft Office