Koosha Heidari

About Koosha Heidari

Medical Device Engineer with expertise in manufacturing, automation, and project management. Skilled in leading cross-functional teams, implementing cost-reduction projects, and ensuring FDA compliance. Recently earned an MBA with a focus on healthcare and business strategy.

Experience

1. Product Design Engineer ll

   ICU Medical

   Jun 2024 — Present

   Led development of the Low Oil MicroClave, reducing silicone usage 10x, achieving FDA approval, and saving $400K annually through cleanroom automation. Authored and executed IQ, OQ, PQ, and FAT protocols.• Managed cross-functional projects across regulatory, quality, and manufacturing teams at multiple U.S. sites using Smartsheet and MS Project to track scope, budget, and timelines.• Traveled over 40% to manufacturing plants to lead implementation, train operators, and present updates to engineering teams.• Led risk mitigation meetings and regularly presented project status, risks, and recommendations to senior management.• Designed a semi-automated dispensing system (SolidWorks, PLC), overseeing development across sites and ensuring seamless deployment.• Studied competitor products, performed benchmarking tests, and provided insights to ensure technical leadership, supporting the marketing team with data-driven positioning strategies.

Education

• University of California, Riverside

  Bachelor's degree, Biology/Biological Sciences, General

• University of California, Irvine - The Paul Merage School of Business

  Master of Business Administration - MBA

• Saddleback College

  Associate of Science - AS, Biology/Biological Sciences, General