Dustin Leslie

About Dustin Leslie

Strategic and solutions-driven Project Management Leader with over X years of experience delivering complex, cross-functional initiatives in the Medical Device, Pharmaceutical, Vaccine, and Diagnostics industries. Adept at guiding programs from early-stage R&D through clinical trials, regulatory submissions, manufacturing scale-up, and global commercialization — ensuring full compliance with FDA, EMA, ISO 13485, and GxP standards.Proven track record of accelerating time-to-market, managing multi-million-dollar budgets, and leading high-performing teams to deliver projects ahead of schedule, under budget, and with exceptional compliance outcomes.Core Expertise:• Regulatory Submissions – 510(k), PMA, IND, NDA, CE Mark• Quality Systems – ISO 13485, CAPA, Design Controls, Risk Management• Operational Excellence – PMO Implementation, Process Optimization, Lean Six Sigma• Cross-Functional Leadership – R&D, Quality, Regulatory, Manufacturing, Marketing, Supply ChainSelect Achievements:• Reduced product launch timelines by 35% through streamlined governance and risk mitigation strategies.• Managed $5M+ budgets and teams of 10+ across multiple sites to deliver high-priority programs with zero major audit findings.• Successfully navigated global regulatory pathways, enabling launches in 20+ countries.Passionate about advancing healthcare by ensuring innovative solutions reach patients faster, safer, and more reliably.

Experience

1. Project Manager

   Ametek Pacific Design Technologies Pdt

   Oct 2025 — Present

Education

• UC Santa Barbara

  Bachelor of Science (BS), Chemical Engineering

  2002 — 2006

Skills

• Chemical Engineering
• Chemical Formulation
• Iso 10993
• Change Management
• Biotechnology
• Research and Development (R&D)
• Change Control
• Gmp
• Product Development
• Medical Devices
• Capa
• Experimental Design
• Insourcing
• Management
• X-Ray Ct
• Agile Project Management
• Fda
• Laboratory
• Project Planning
• Engineering
• Strategic Planning
• Regulatory Submissions
• Cross-Functional Team Leadership
• Sop Development
• Leadership
• R&D
• Biomedical Devices
• Microsoft Powerpoint
• Iso 13485
• Data Analysis
• Product Launch
• Microsoft Project
• Hplc
• Project Coordination
• Employee Training
• Manufacturing
• Microsoft Excel
• Report Writing
• Microsoft Office
• Design Control