Description
I have ample experience in design, operating, servicing and troubleshooting of medical devices mechanical and electromechanical systems. I am a skilled Sr. engineering technician, collecting, analyzing and interpreting data provided by devices, clinicians and operating personnel to diagnose and repair the system failures, and transfer the information to system engineers. I have provided and/or performed preventive maintenance (PM), repairs, calibration, safety and functionality testing, and system installation as well as field emergency services to specialized medical equipment such as complex In-Vitro diagnostic devices. I maintain a working knowledge of applicable federal, state and local regulations such as OSHA, USFDA 21 CFR 820, ISO13485, and IVD EU Directive 98/79/EC as well as industry standards. I fully comply with the company's Standards of Conduct, and other work policies and procedures in order to ensure adherence in a manner that reflects my ethical and professional integrity.
Work Experience
COMPANY | POSITION HELD | DATES WORKED |
---|---|---|
(Confidential) | Qa/ Cf Analyst, Quality Assurance Department Sr. Engineering Technician, Manufacturing Engineering Department | 1/2018 - Present |
Iris | Lead Technician Mechanical Engineer Independent Quality Consultant | 11/2010 - 4/2014 |