About this Candidate
DAVRON CV: Candidate 3812530
BIOMEDICAL ENGINEER | MEDICAL DEVICE R&D, DESIGN CONTROLS & QUALITY SYSTEMS
Core Expertise
- Human-centered design and VOC research translating clinical workflows into product requirements and prototypes.
- Medical device design controls, DHF management, and regulatory strategy for 510(k) submissions.
- Quality systems leadership: led QMS overhaul from FDA 21 CFR Part 820 to ISO 13485 conformance.
- Verification and validation planning, test method validation, DOE, gage R&R, and SPC/Cp/Cpk analysis.
- Rapid prototyping and benchtop testing including 3D printing, material selection, and design transfer support.
Project Background
- Led five-person team developing a Class II physiological monitoring device through V&V and regulatory planning.
- Designed and documented 100+ patient-specific surgical devices using advanced surface modeling and 3D printing.
- Developed a usage-tracking feature from VOC research to prototype, resulting in a filed patent application.
- Overhauled QMS by rebuilding 20+ SOPs, work instructions, and quality records to meet ISO 13485.
- Supported FDA audit preparation with FMEA, CAPA, DHF, DMR/DHR, and design transfer activities.
Key Skills
- SolidWorks | Fusion 360 | Geomagic Freeform
- Python | Raspberry Pi | MATLAB | R
- ISO 13485 | FDA 21 CFR Part 820/QMSR | ISO 14971
- Design controls | DHF | DMR/DHR | 510(k) strategy
- Prototyping & fabrication: 3D printing | material selection | benchtop testing
- V&V & test methods: DOE | Gage R&R | SPC | Cp/Cpk | test method validation
Education
- M.S., Biomedical Engineering — Georgia Institute of Technology, MBID Program
- Certificate, Industrial Design — Georgia Institute of Technology
- B.S., Biomedical Sciences — University of Central Florida (Honors thesis)
Awards & Recognition
- Lean Six Sigma Yellow Belt
Why Interview this Candidate?
They combine hands-on medical device R&D with demonstrated quality and regulatory leadership, including a company-wide QMS overhaul to ISO 13485 and successful FDA audit support. Experienced in taking concepts from VOC through prototyping, V&V, and 510(k) planning, they deliver measurable improvements and robust documentation. Ready to apply technical breadth and process rigor to accelerate product development and compliance.
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