David Gorgi

Experience

1. Principal Mechanical Engineer

   Baxter International Inc.

   Apr 2018 — Present

   Lead Designer for Enclosure Subsystem, leading a team of engineers for a medical device infusion pump program and HUB/Rack system - Product Design Owner (PDO) for an existing medical device infusion pump globally distributed - Mechanical Subject Matter Expert (SME) on the Power Subsystem for New Product Development (NPD)- Identified creative solutions to complex mechanical problems, define and execute plans to rapidly assess and optimize designs - Used analytical methods to assess designs such as tolerance analysis, FEA, and other mechanical engineering methods - Developed and executed statistically valid testing to verify design meet product requirements - Experienced in generating design and test documentation that meets company, FDA and ISO requirements/standards - Failure Mode Effects Analysis (FMEA) and risk mitigation competency on both new product development and sustaining projects/activities - Demonstrated root cause analysis and problem solving skills - Cross functional team experience across global sites (US, Canada, LATAM, India, Asia, EU)

Skills

• Sop
• Continuous Improvement
• Dmaic
• Root Cause Analysis
• Design of Experiments
• Change Control
• Fda
• R&D
• Microsoft Office
• Design Control
• Medical Devices
• Process Improvement
• Quality System
• Validation
• Capa
• Minitab
• Engineering
• Cross-Functional Team Leadership
• Fmea
• V&V
• Six Sigma
• Gmp