Engineering Manager

  • by
Location
Candidate No.
1960700

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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