Jesse Smith

Experience

1. R & d Director - Software & Systems

   BD

   Mar 2018 — Present

   Role: • Lead a cross-discipline R&D team within the Targeted Temperature Management business unit. • Support execution, innovation, and collaboration across the organization • Partner with cross-functional leaders across quality, regulatory, marketing, manufacturing, and clinical to enable the successful development of innovative products. • Ensure programs deliver to scope, budget, and timelines and ensure that quality metrics (complaint rates, CAPAs, etc.) meet, or exceed, expectations. • Work across multiple business divisions to drive corporate initiatives. • Manage a $3.5M R&D development budget • Oversee new technology development for Sudden Cardiac Arrest, Stroke & Traumatic Brain injured patients.(Data analytics, SW architectures for connected systems, and more) • Develop and maintain the Arctic Sun platform.(Console and disposable) • Regular presentations to Senior Leadership on TTM R&D strategy and status updates • Lead a cross-divisional Leadership Team effort on INTREPID clinical trial strategy • Work with global engineering teams in India and Ireland • Support sales and work with customers (surgeons, nurses, or biomeds) to resolve field issues Major Accomplishments: • Led the development team in launching the Arctic Sun STAT – Next generation Arctic Sun Console • Led the scoping effort for the international release of the AS STAT • Co-Led the scoping effort for the Next Generation Gel Pads (Disposables for Arctic Sun)

Education

• Brigham Young University

  BS, Electrical Engineering

• Duke University

  MS, Engineering Management

Skills

• Capa
• R&D
• Quality System
• Failure Mode and Effects Analysis (Fmea)
• Design of Experiments
• Iso 13485
• Embedded Systems
• Electronics
• Corrective and Preventive Action (Capa)
• Validation
• Minitab
• Research and Development (R&D)
• Fmea
• Iso 14971
• Pcb Design
• Manufacturing
• Analog Circuit Design
• Root Cause Analysis
• Labview
• Medical Devices
• Product Launch
• Design Control
• Engineering Management
• Fda
• Research and Development (R
• Solidworks
• Manufacturing Engineering
• Biomedical Engineering
• Firmware
• U.s. Food and Drug Administration (Fda)
• V&V
• Design for Manufacturing