About this Candidate
DAVRON CV: Candidate 1960700
MANUFACTURING & PRODUCT DEVELOPMENT LEADER | MEDICAL DEVICES | SCALE-UP & QUALITY SYSTEMS
Core Expertise
- Manufacturing leadership for FDA-regulated medical devices, including scale-up and production launch.
- New product introduction, design transfer, DFM/DFA, and design control compliance.
- Quality systems ownership: ISO 13485, ISO 9001, IEC 60601 readiness and change control.
- Supplier quality, qualification, audits, PPAP, and vendor management for critical components.
- Continuous improvement and Lean methods driving reduced cycle times and material usage.
Project Background
- Built manufacturing systems from scratch: SOPs, WIs, WIP controls, inspection, and documentation workflows.
- Scaled production capacity through layouts, capacity models, inventory controls, and additive manufacturing.
- Led verification and testing activities to support medical electrical safety and regulatory readiness.
- Directed supplier qualification programs, audits, and second-source supplier development for risk mitigation.
- Implemented process improvements and fixtures that increased yields from ~55% to nearly 90%.
Key Skills
- SolidWorks | Fusion 360 | Mastercam | PLM systems
- GD&T | Tolerance analysis | Fixture and tooling design
- Lean manufacturing | Continuous improvement | Minitab
- Design controls | Risk management | Change control | DFx
- Supplier quality | PPAP | Vendor audits | Supplier qualification
Education
- M.S., Mechanical Engineering — California State University, Long Beach
- B.S., Mechanical Engineering — University of California, Irvine
Awards & Recognition
- Six Sigma Green Belt
Why Interview this Candidate?
They are a manufacturing and engineering leader with 12+ years delivering NPI, scale-up, and quality systems in regulated medical device environments. Built manufacturing systems from the ground up, led cross-functional teams, and achieved measurable yield and efficiency gains, enabling faster commercialization and improved operational performance.
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