About this Candidate
DAVRON CV: Candidate 1858027
MECHANICAL ENGINEER | MEDICAL-DEVICE R&D | DESIGN TRANSFER & V&V
Core Expertise
- Leading design transfer and manufacturing readiness for medical devices, including DHF management
- Implementing FDA design controls, authoring DVPs/DVRs, and managing design history files
- Planning and executing verification & validation and test method validation (TMV) programs
- Cross-functional leadership with R&D, Quality, Regulatory, Manufacturing, and Supply Chain
- Cost-reduction through design transfer, achieving over $200K in documented savings
Project Background
- Designed orthopedic surgical instruments and guides, iterating with clinicians through cadaver-lab feedback
- Led multiple surgical-template programs through full new-product development lifecycle to commercialization
- Managed injection-molding projects coordinating two technical teams (~12 people) to deliver on schedule
- Developed aseptic IV-bag filling concepts and prototypes that progressed to a patent application
- Created ASTM-aligned vibration test method adopted division-wide for case and tray testing
Key Skills
- Creo | SolidWorks | AutoCAD
- Medical device NPD | Design transfer | DHF | FDA design controls
- Verification & Validation | Test Method Validation | Protocols & reports | ASTM testing
- Rapid prototyping | 3D printing | Machining | Engineering drawings
- Supplier coordination | Manufacturing readiness | CAPA coordination
- Project management: Microsoft Project | Excel | Jira
Education
- M.S.E., Mechanical Engineering — Johns Hopkins University
- B.S., Mechanical Engineering — Lafayette College
Awards & Recognition
- Patent application filed for aseptic IV-bag filling concept
- ASTM-aligned vibration test method adopted as division standard
Why Interview this Candidate?
They offer 8+ years of hands-on medical-device R&D experience driving products from concept to commercialization, including design transfer and V&V. Demonstrated ability to lead cross-functional teams, author regulatory-compliant DHF documents, and deliver measurable cost savings. Ready to apply technical depth and project leadership to accelerate product development and manufacturing readiness.
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