Manufacturing Engineer

DAVRON CV: Candidate 1958395

SENIOR MANUFACTURING & R&D ENGINEER — MEDICAL DEVICES | PROCESS DEVELOPMENT & SCALE-UP

Core Expertise

• Medical device manufacturing scale-up for Class II and Class III products under FDA and ISO 13485.
• Process development and validation including IQ/OQ/PQ, test method development, and SPC implementation.
• Automation, robotic assembly, and tooling design using SolidWorks to increase throughput and reduce scrap.
• Cleanroom planning, layout, installation, and qualification for ISO Class 7–9 production environments.
• Regulatory and quality leadership: design controls, DHF/DMR/DHR documentation, risk management, and CAPA processes.

Project Background

• Led automation projects that increased production efficiency by 15% while reducing operator-related scrap below 2%.
• Directed cleanroom construction and qualification for a 2,000 m² facility supporting high-volume medical manufacturing.
• Managed a capital expansion to establish high-volume silicone catheter and shunt production, increasing capacity 80%.
• Executed manufacturing transfers and NPI activities, producing validated processes, work instructions, and operator training.
• Developed EO-sterilization-compatible packaging, PVP coating processes, and semi-automated packaging tooling for scale-up.

Key Skills

• SolidWorks | PTC Windchill | Veeva Vault
• Process Validation (IQ/OQ/PQ) | Test Method Development | SPC
• Lean Manufacturing | Six Sigma | Root Cause Analysis (CAPA, 5 Why, Fishbone)
• GD&T | DFM/DFA | Fixture and Tooling Design
• Cleanroom Design & Qualification | Contamination Control | EO Sterilization Packaging
• Minitab | ERP Systems | Microsoft Office

Education

• M.S., Mechanical Engineering — University of Houston
• B.S., Electrical & Electronics Engineering — Dumlupinar University
• B.S., Mechanical Engineering

Awards & Recognition

• ISO 13485 Medical Device Quality Management Systems training certification
• FDA 21 CFR Part 820 and Design Controls compliance training
• Process Validation (IQ/OQ/PQ) and GMP medical device compliance training

Why Interview this Candidate?

They bring a rare combination of hands-on product development, manufacturing transfer, and automation experience in FDA- and ISO-regulated environments. Demonstrated history of driving measurable outcomes—capacity increases, scrap reduction, and validated scale-up—while leading cross-functional teams. Ready to lead NPI, validation, and continuous improvement efforts to accelerate production readiness and quality.