Senior Advanced Manufacturing Engineer

  • by
Candidate No.
3823909

About this Candidate

DAVRON CV: Candidate 3823909

SENIOR ADVANCED MANUFACTURING ENGINEER | MEDICAL DEVICES | DESIGN TRANSFER & VALIDATION

Core Expertise

  • Advanced manufacturing engineering for regulated medical devices, focusing on design transfer and validation.
  • Leading cross-functional teams to develop, qualify, and scale manufacturing processes and equipment.
  • IQ/OQ/PQ and equipment qualification expertise across capital projects and process installations.
  • Statistical process characterization, DOE execution, and data-driven decision making using Minitab.
  • Supplier qualification and PPAP execution with procurement alignment to meet quality and lead-time targets.

Project Background

  • Managed design transfer and sustaining R&D for a marketed minimally invasive device, driving complaint-driven improvements.
  • Developed processes for molding, lyophilization, laser cutting/welding, and complex assembly technologies.
  • Led FAT through IQ/OQ/PQ cycles for new equipment installations and production ramp-up.
  • Designed and executed DOE and process characterization studies to reduce variability and enable production readiness.
  • Prepared regulatory and validation documentation supporting submissions, change control, and quality-system compliance.

Key Skills

  • Minitab | DOE | Statistical Process Control
  • IQ/OQ/PQ | Equipment Qualification | FAT
  • Process Development | Design Transfer | Manufacturability Analysis
  • PPAP | Supplier Qualification | Supplier Collaboration
  • SolidWorks | Tulip | Microsoft Project | MS Office
  • Test Method Validation | TMV | Change Control | Validation Reporting

Education

  • B.S., Chemical Engineering — University of Oklahoma
  • A.S., Pre-Pharmacy Studies — Oklahoma City Community College

Why Interview this Candidate?

A proven manufacturing engineer with 6+ years in regulated medical-device environments and progressive promotions. Brings hands-on expertise in design transfer, IQ/OQ/PQ validation, equipment qualification, and DOE-driven process optimization. Strong collaborator across design, quality, suppliers, and procurement to accelerate production readiness and maintain regulatory compliance.

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