Samuel Evans Email & Phone Number

Logan, Ut, Us

Salt Lake County, Utah, United States

New Britain, Pa

Norristown, Pa

I oversaw product development of class III medical devices – transcatheter aortic valve and delivery catheter. I developed projects from concept generation to patient use. I was involved in all pre-clinical testing in accordance with ISO 5840 and ISO 10993 standards. I sourced and managed OEM supply chains, testing facilities, and manage the technical aspects of two international license partners. Specific responsibilities and expertise included:• Product development: TAV (multiple sizes and designs), catheter delivery systems (1st & 2nd generation), and loading devices. I have been instrumental in bringing products from concept generation to First-In-Human clinical settings.• Development of risk analysis, product specifications, device history files, and other ISO 13485 quality system documentation.• Pre-submission meetings with FDA (face-to-face in Bethesda, MD), regulatory submission for Health Canada, and interactions with European Notified Bodies (DEKRA & BSI).• Physician training using in-vivo animal studies and in-vitro simulators with internationally renowned interventional cardiologists and cardiothoracic surgeons, with continued collaboration for product development.• Familiar with catheterization labs and hybrid operating suites from pre-clinical animal testing and training to First-In-Human clinical experience. • Assistance with writing provisional and utility patents• Fundraising and business efforts: writing funding proposals, pitching to venture funds and angel groups.

Norristown, Pa

Processed patient samples in a pathology laboratory to decontaminate and prepare microscope slides to diagnose mycobacterium diseases and report critical results to physicians in a timely manner.

Gathered technical information for a chronic, GLP animal study for a left ventricular assist device. This study was conducted at the animal resource center at the University of Utah.

M.S., Biomedical Engineering

B.S., Biology