Kenneth Nelson Email & Phone Number

Alameda, California, United States

Plano, Texas, United States

Provided mitigations for over 10000 use errors to meet submission criteria and gain project approval● Designed protocols to simulate and test HF (Human Factors) issues and MRI compatibility for compliance● Analyzed clinical data to identify trends and patterns for improving surgical and medical device use protocol● Presented data analysis to cross-functional teams, aligning leadership around FDA and EUMDR compliance● Reviewed ISO and BS EN regulation, writing compliance reports that ensured strict adherence to regulatory standards● Prepared and submitted DHFs, FMECAs, EUMDR and FDA documentation for product approval● Performed gap assessments for design submissions based on new EU requirements, ensuring regulatory compliance

Irvine, California, United States

● Conducted tissue bench testing to identify and address development needs, that improved product design and function● Created tools to generate graphics of and analyze data from device for Test Reports and FDA submissions● Assisted in the operation, data collection and analysis of preclinical animal trial studies to show product effectiveness● Authored and edited test reports and test protocols for high volume clinical trials as well as pre-clinical and animal studies● Created presentations and analysis summaries to support physician participation in clinical trials● Analyzed histological, phlebotomy, and device data for preclinical trial review

Master'S Degree, Bioengineering And Biomedical Engineering

Activities and Societies: Tau Beta Pi

Education record