Michael Nasuta

About Michael Nasuta

I am a program director, biomedical engineer, and proven leader with 19 years of medical…

Experience

1. Sr Program Manager Core Team Leader

   BD

   Nov 2019 — Present

   In this role I lead cross-functional Core Teams in executing all aspects of product development and improvement; from concept definition, into development and verification and validation, through clinical trials, worldwide regulatory clearance/registration, and through a successful commercial launch. I am responsible for the execution, quality and results of the project, and the success of the resulting product in the market, including achieving strategic and financial objectives while achieving the cost, schedule, and performance goals of the project. My current focus is developing, improving, and sustaining products for the at home, self testing market for respiratory diseases. Key Accomplishments- Led development of a new PCR assay for an emerging STI, migration of a multiplex PCR assay to a high throughput automated instrument, and the launch of a new, multi-use collection device- Managed a partnership with US government agency to conduct a landmark clinical trial for serial, asymptomatic testing of at-home COVID-19 tests resulting in industry-wide guidance for serial testing of COVID-19 antigen tests - Developed the informatics solution for at-home COVID-19 test results storage, reporting to public health authorities, and integration with enterprise partners meeting OSHA guidelines - Launch of Canadian at-home COVID-19 test and smartphone app - Launch of Integrated Informatics solution for POC Testing Device Awards & Recognition: Promoted from Project Manager to Program Manager to Senior Program Manager 2 Teams awarded Honorable Mention for 2022 IDS President\'s Award for Innovation \"Chaos Coraller Award\"- IDS PMO Oscars 2022

Education

• The George Washington University

  Certificate, Project Management

• Smartly Institute

  Fundamentals of Business Certificate

• Western Michigan University

  MSE, Industrial Engineering

• The Johns Hopkins University

  Master's, Biotechnology Enterprise & Entrepreneurship

  2021 — 2025

• Washington University in St. Louis

  BS, Biomedical Engineering

Skills

• Product Launch
• Failure Analysis
• Six Sigma
• Lean Manufacturing
• V&V
• Research and Development (R&D)
• Medical Devices
• Design of Experiments
• Fda
• Cross-Functional Team Leadership
• Business Process Improvement
• Root Cause Analysis
• Process Improvement
• Product Development
• Fmea
• Quality Assurance
• R&D
• Capa
• Product Management
• Validation
• Continuous Improvement
• Quality System
• Project Management
• Iso 13485
• Failure Mode and Effects Analysis (Fmea)
• Design Control
• Biomedical Engineering
• International Marketing