| Position Medical Device Design Engineer Specializing in Spine Profession Mechanical Engineer Timeline 6 years 10/2014 - Current Captiva Spine, Inc. in Jupiter, FL 10 years 4/2004 - 7/2014 Atlas Spine, Inc. in Jupiter, FL 6 years 1/1998 – 4/2004 Sub-Sea Robotic Vehicles in Jupiter, FL 2 years 9/1995 – 12/1997 CAD Software Engineer in Orlando, FL 4 years 6/1991 – 6/1995 College of Engineering at UF in Gainesville, FL Skills - Application of engineering principles to the design of spinal implants, instruments and sterilization trays
- Optimizing all designs to maximize cost reductions for manufacturing including 3D printing, traditional machining and EDM
- Creating manufacturing prints for ease of manufacturing and inspection
- Designing implants and instruments within FDA 21 CFR 820 Design Controls environment including creation of all documents through all phases of development
- Establishing and executing all verification and validation activities
- Evaluating and documenting defective implants, instruments and processes to determine root-cause and appropriate corrective actions
- Establish and execute detailed tolerance analysis to insure the viability of proposed interfacing implants and/or instruments
- Experience with and knowledge of spinal surgical procedures and OR practices
- Extensive experience teaching and creating 3D CAD models, assemblies and drawings using SolidWorks within a PDM environment
Contact Info Layne Johnson 2732 Lone Pine Rd. Palm Beach Gardens, FL 33410 (561) 222-4923 layne@johnsonwithat.com |