Mickey Iotov

Experience

• 

  Roche Molecular Systems

  Jun 2012 - Sept 2012

  Summer Intern

  Tested new assay software in lab and recorded issues using an international online databaseWrote laboratory procedures for satisfying technical requirements

• 

  Roche

  Jun 2013 - Mar 2024

  • Systems Engineering specialist on multiple parallel projects• Development of PCR diagnostic assays on cobas 4800, 5800, 68/8800, s201, and VivoDx platforms• Author of high-quality documents for FDA submission such as feasibility experiments, requirements management, system verification, system configuration management, & risk assessment• Systems Verification Lead for one of the first FDA Emergency Use Authorized Sars-Cov-2 PCR tests in the US• Expert in data analysis from a variety of platforms, for in-house & customer field data• Expert in liquid handling optimization and automation• Team lead on performing tasks from feasibility experiments to quality system and component V&V• Collaborator to various departments as Research, Assay, Product Care, Clinical Operations, & Regulatory• Contributor to approval of SARS-CoV-2 (authorized), Malaria, Babesia, CT/NG, HPV, HBV, HIV, HCV Genotyping• Consumables Validation Lead on new manufacturing lines for cobas 68/8800 during supply shortages• Requirements Manager - Design, Update, and Trace requirements to ensure testing coverage• Configuration Manager - Create & maintain entire system and component configurations Show less

  • Senior Systems Engineer

    Mar 2021 - Mar 2024

  • Systems Engineer II

    Mar 2018 - Feb 2021

  • Systems Engineer

    Apr 2015 - Feb 2018

  • System Engineer

    Jun 2013 - Mar 2015
• 

  Natera

  Oct 2024 - now

  Software Quality Assurance Engineer III