Donald Shannon
Medical Device Engineering
- Role
- Senior Consultant at Square-1 Engineering
- Location
- New Bern, NC, US
- LinkedIn followers
- 500 followers
About Donald Shannon
Thirty years of medical device experience resulting in eighteen issued US Patents.Ten years of management experience leading R&D and cross-functional development teams.Experienced in Vascular, Neurovascular, Cardiovascular and Endovascular devices with a solid understanding of design control, GLP and CGMP. I have teamed to launch over seven unique products involving both 510k and PMA.Energetic Quality Professional who applies Quality Sciences in R&D and New Product Development yielding excellent manufacturability.Product experience includes ePTFE Vascular Grafts, Nitinol, Elgiloy and Stainless Steel Stents, Coverings for Stents, Endovascular Grafts, Dental Implants, Biologic and Carbon Heart Valves, Delivery Catheters, Sutures, Ligaments, Left Ventricular Assist Device, and Early Cannulation Technology. SME for ePTFE processes and applications.Engineering experience includes Process Specific Machine Building, Control System Design, Automated Production Machines, Polymer Processes, Metal Applications, Voice of Customer, Design Control, Quality System Development, Validations, DOE, Research, Clean Room Design, LEAN Practices, SPC, Facility Design, Facility Maintenance, Packaging and Test Equipment, Quality and Fundamental Statistics Training.
Experience
Senior Consultant
Present
V&V Protocol and Reports at BIT-Group Irvine, CA
Education
Northern Arizona University
Bachelor of Science (B.S.), Electrical and Electronics Engineering
1980 — 1985
Skills
- Quality Assurance
- Design for Manufacturing
- Process Engineering
- Biomedical Engineering
- Six Sigma
- Quality Auditing
- Spc
- Quality Control
- Gmp
- Injection Molding
- Validation
- Medical Devices
- Regulatory Affairs
- Capa
- Iso 9000
- Fmea
- Minitab
- Testing
- Continuous Improvement
- Quality Management
- Iso
- Sop
- Fda
- Tqm
- Design of Experiments
- Manufacturing
- Product Development
- 5s
- R&D
- Manufacturing Operations Management
- Engineering
- Value Stream Mapping
- Quality System
- Process Simulation
- Dmaic
- Manufacturing Engineering
- Electronics
- Software Documentation
- Engineering Management
- Root Cause Analysis
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