Engineering Technician
Rancho Santa Margarita, California, United States
• Investigated and analyzed medical device complaints.• Evaluated products returned by the customer to determine design and/or manufacturing non-conformances, use errors, or other conclusions related to the event, as well as reviewed the details surrounding the customer complaint.• Used root cause analysis and failure analysis techniques to investigate, assess, and reach conclusions on customer events.• Composed detailed reports to document results from customer experience investigations, which included analysis and trending of quality data, proposing corrections, corrective actions and/or preventive actions, and incorporation of risk management, ensuring patient and user risk was minimized and acceptable.• Acted as a Certified Investigator with responsibilities to review and approve complaint investigations related to medical devices.• Modified and updated engineering documents which included manufacturing instructions, drawings, test procedures, and other documents related to regulatory affairs.• Performed Engineering Evaluations, process capability studies, and other time/performance studies.• Developed and executed protocol for device testing, device and component manufacturing, and device utilization.