Education:
University of Colorado, College of Engineering, Boulder, CO
B.S. Chemical and Biological Engineering, May 2011
Work Experience:
World Panel Inc, October 2014 – Current
Senior Development Engineer
• Manufacturing Project Manager (Internal/External Manufacturing)
• ISO9001 Quality Assurance System Development/Implementation
• Production/Facility Planning
• Product Development (New Product Conception, Design Control, Solidworks CAD, Verification and Validation Protocol Development/Testing)
• Supplier Selection, Logistics, Production
• Expansion/Scale-up Strategic Planning
• Employee Management/Hiring
• International Sourcing/Manufacturing/Business Development
World Panel Inc, March 2014 – October 2014
Product Development/Quality/Manufacturing Consultant
Crosstrees Medical Inc, September 2011 – Current
Project Engineer
• Product Development (Solidworks, Product/Print Design, V&V Testing)
• Quality Assurance (ISO13485, FDA, CAPA, Complaints, Nonconformance)
• Supplier Evaluation
• Clinical Trial Database/Inventory Management Software Development (SQL)
• Creation and Maintenance of Design History Files
Research Associate II
• Clinical Trial Data Management
• Clinical Trial Monitoring
• Clinical Operation Management
• FDA/GCP/ICH Regulation and Guidance Compliance
• Physician Interaction
Professional Training:
- Boothroyd Dewhurst: Design for Manufacturing and Assembly (DFM/DFA), Product Costing and Simplification, October 2014
- Fortress Medical Systems: Clinical Database Development, Clinical Trial Study Management, Clinical Trial Data Management, May 2012
- Medical Research Management: Medical Devices/In-Vitro Diagnostics and Clinical Research, Clinical Trial Responsibilities, Monitoring Activities, Adverse Event Identification and Reporting, Regulatory Pathways of IDE and 510k Applications, March 2012
Computer Proficiencies:
Solidworks CAD, Fortress Medical Systems Clindex, Aspen Plus, Aspen Hysys, Aspen COMThermo, Excel, Access, Word, Powerpoint, Adobe Photoshop, Adobe Illustrator, Adobe InDesign, MathCAD, Matematica, SuperPro, DICOM
Equipment:
Laser Cutting/Processing, Multi-axis Fluid Dispensing, Solar Module Lamination, 3D Printing...
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