Adam James Clark
Engineers at 65 Pl, Arvada, CO

Global Health Innovations Fellow at Jhpiego, Chief Regulatory Officer at Salveo Vascular, Advisory Board Member at Archon Medical Technologies, LLC

Medical Devices

Jhpiego - Greater Denver Area since Jul 2012 - Global Health Innovations Fellow Salveo Vascular - Greater Denver Area since Oct 2011 - Chief Regulatory Officer Archon Medical Technologies, LLC since Oct 2011 - Advisory Board Member The Johns Hopkins University - Baltimore, Maryland Area Oct 2011 - May 2012 - Teaching Assistant/Mentor for Undergraduate Design Team Projects Baxa Corporation Feb 2011 - May 2011 - Mechanical Engineer Reglera Oct 2009 - Feb 2011 - Quality Engineer II CaridianBCT May 2007 - Oct 2009 - Engineer CaridianBCT 2006 - 2007 - R&D Engineer Intern

The Johns Hopkins University 2011 - 2012
MSE in Bioengineering Innovation and Design, Biomedical Engineering University of Colorado Boulder 2003 - 2007
BS, Mechanical Engineering

Medical Devices, Biomedical Engineering, Solidworks, Design Control, FDA, Product Development, Validation, CAD, R&D, Design of Experiments, Engineering, V&V, Global Health, Cross-functional Team Leadership, Human Factors Engineering, Global Regulatory Compliance, Disposables, Intellectual Property, Project Management, Stakeholder Management, Business Strategy, Lean Manufacturing, Design for Manufacturing, User-centered Design, Public Speaking, Proposal Writing, Grant Writing, Fundraising, Biotechnology, Product Design, Mechanical Engineering, International Travel, Clinical Study Design, Manufacturing Operations, SPC, Machining, Root Cause Analysis, Matlab, ISO 13485, Finite Element Analysis, Minitab, Mathematica, Labview

Boettcher Scholar 2003: Full scholarship to any university in Colorado. The oldest and most prestigious merit-based scholarship in the state, given annually to 40 students since 1952. Highly competitive application process with over 1300 applicants. Selection criteria are superior academic ability, leadership, service, and outstanding character.

English, Spanish

Jhpiego
Global Health Innovations Fellow Archon Medical Technologies, LLC
Advisory Board Member Salveo Vascular
Chief Regulatory Officer Baxa Corporation - Englewood, CO
Mechanical Engineer Reglera LLC - Lakewood, CO
Quality Engineer II CaridianBCT, Inc - Lakewood, CO
Disposables Manufacturing Engineer CaridianBCT, Inc - Lakewood, CO
Research and Development Engineer

The Johns Hopkins University - Baltimore, MD
Master of Science in Engineering, Bioengineering Innovation & Design University of Colorado at Boulder - Boulder, CO
Bachelor of Science in Mechanical Engineering Johns Hopkins Medical Institute
Clinical Immersion

Product Development: Cross-Functional Team Leadership, Medical Device Innovation & Design, Verification and Validation Testing, SolidWorks, Lean Manufacturing, Frugal Engineering, RF Welding, Disposables, Fabrication, Ultrasonic Welding, Catheter Manufacturing, Gamma Irradiation, Steam and Ethylene-Oxide Sterilization, Mass Flow Leak Testing, Technical Writing for Grants and Journal Publications, Microsoft Office, Minitab, Design of Experiments, Statistics, Human Factors Engineering, User-Centered Design, Finite Element Analysis, SPC. Quality System and Regulatory: 21 CFR Part 820, ISO 13485/9001, CAPA, Risk Assessment, Complaint Resolution, Route to Market Strategy, Clinical Study Design, Audit Experience (DHF, Design Controls, QMS), Investigational Device Exemptions, New Drug Approvals, 510(k) submissions. Business: Intellectual Property, Reimbursement, Market Entry & Commercialization strategy, Stakeholder Management, Project Management, Market/Landscape Analysis