Shannon leads the high-performance team of experienced human factors, biomedical engineers, and instructional design experts to support Agilis’ US and global clients from early-stage user research, through regulatory submission and post-market surveillance. She is an expert in human factors and product development processes with over 20 years of experience in the industry.
· 20+ years in the medical device, IVD, and combination products industry
· Served as Human Factors Team Lead within the FDA
· Optimized product development, risk management, and human factors processes for multiple companies from start-up to Fortune 100
Areas Of Specialty:
· Human factors and regulatory strategies
· Medical device product development process
· Systems Engineering with focus on Requirements, Risk Management, Verification and Validation