About this Candidate
DAVRON CV: Candidate 35593
SENIOR MEDICAL‑DEVICE PROJECT ENGINEER | PRODUCT DEVELOPMENT, VALIDATION & MANUFACTURING TRANSFER
Core Expertise
- Regulated medical-device product development from concept through production, including design controls and 510(k) support.
- Validation leadership covering IQ/OQ/PQ, equipment and process qualification, and sterilization validation.
- Manufacturing transfer and process optimization to reduce waste, downtime, and improve manufacturability.
- Cross-functional project management coordinating engineering, quality, operations, vendors, and customers.
- Electromechanical and catheter design with CAD-driven 3D modeling, prototyping, and tooling experience.
Project Background
- Led portfolios of approximately five concurrent development and transfer projects, managing budgets and schedules.
- Directed multidisciplinary teams of about ten engineers, manufacturing, and quality personnel to meet milestones.
- Authored IQ/OQ/PQ protocols, validation reports, work instructions, DCNs, NCRs, and regulatory documentation.
- Executed installation, operational, and performance qualifications plus process studies and Six Sigma capability analyses.
- Managed transfer and scale-up of extrusion, injection molding, bonding, and sterilization into production.
Key Skills
- Design controls | 510(k) support | FDA QSR 21 CFR Part 820 | GMP | ISO 9000
- IQ/OQ/PQ | Equipment and process validation | Sterilization validation
- SolidWorks | Solid Edge | AutoCAD | 3D modeling | Prototyping | Tooling
- Manufacturing transfer | Extrusion | Injection/insert molding | Bonding | Packaging
- Project management | Budgeting | Capital planning | Gantt scheduling | Cross-functional leadership
- SAP | Document control | DCNs | NCRs | Work instructions
Education
- Mechanical engineering coursework — Penn State University / Camden County College
- Associate degree, Architecture — Lincoln Tech
- Additional training: Solid Edge, SolidWorks, AutoCAD
Why Interview this Candidate?
Seasoned medical-device engineer with 30+ years in regulated product development, validation, and manufacturing transfer. Proven record managing multiple concurrent projects and multidisciplinary teams while authoring regulatory and validation documentation. Strong hands-on CAD, prototyping, and process-improvement skills enable rapid impact on R&D and manufacturing readiness.
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