Michael Polei, Phd, Pmp Email & Phone Number

Midway, Ut, Us

Salt Lake City, Utah, United States

• Lead a global design team of scientist, engineers, medical and regulatory professionals in the development of medical diagnostic solutions. • Responsible for for project scope, schedule and budget, assurance of quality by design, and supporting internal and external audits in compliance with global Quality System Requirements.• Coordinate globally with design and development project leaders to implement procedures, onboard digital tools and facilitate international team-building.

Greater Salt Lake City Area

• Coordinate efforts to design, develop and launch products including: BioFire Respiratory Panel & associated SPOTFIRE Instrument, FilmArray RP2.1 Panel (FDA's 1st approved SARS-CoV-2 test), and FilmArray Gastrointestinal Panel.• Responsible for developing complete Design History File, performing Risk Management activities, and supporting internal and external audits in compliance with FDA's CFR 820 and ISO 13485 Design Control requirements• Coordinate work with teams across the globe in office, hybrid and remote settings as a meeting facilitator, project leader and Quality Engineer.

Specific Projects• Investigated biological response to brain-implanted microelectrodes by designing in vitro & in vivo biocompatibility evaluation studies and developing quantitative protocols to statically compare results.• Designed an engineered tissue coating for implantable bioelectric devicesAdditional Projects• Designed micro-patterned protein printing process to grow artificial nerve grafts• Development of biological adhesives for scarless wound healing

Greater Salt Lake City Area

Lab coordinator for "Fundamentals of Biomedical Engineering" course in the Department of Biomedical Engineering. Responsibilities included:• Manage three teaching assistants and develop laboratory training exercises• Organize and lead lab sessions for >150 students• Grade submissions, review learning objectives and mentor students

Greater Salt Lake City Area

Graduate training course focusing on application of Nanotechnology in Medicine and Diagnostics.• Experience with Molecular Biophysics, Protein-Surface Binding, Surface Characterization Methods & Molecular Diagnostics

Greater Salt Lake City Area

Osteogenesis LLC is a collaborative effort between the Department of Biomedical Engineering and the Division of Plastic Surgery at Primary Children's Hospital. I have been involved since conceptualization. As CSO my contributions have included:• Clinical interactions with surgeons to document clinical needs in the operating theater• Documentation of Design History File for an implantable craniofacial surgical device under FDA Title 21 CFR part 820• Generation of investment capital though investment pitches, grant writing and participation in competitions• Efforts have produced one pending patent application, investment capital, and inclusion in the National Science Foundation's Innovation Corps.

Greater Salt Lake City Area

• Year-long fellowship focused on documenting design process of medical devices under FDA’s 21 CFR 820 Quality System Regulations• Participated in monthly Design Reviews with regulatory consultants, industry experts and business mentorsMore Info at: https://medicine.utah.edu/surgery/general_surgery/residency/educational-experience/bioinnovate.php

• Demonstrated customer-service excellence: 5 year record of 100% customer satisfaction • Cultivated relationships with small business owners and made recommendations for products and services

Doctor Of Philosophy (Phd), Bioengineering And Biomedical Engineering

Dissertation Title: Addressing the Foreign Body Response to High Density Penetrating Microelectrode Arrays

Masters Of Science (Ms), Biomedical/Medical Engineering

Major: Biomaterials Focus Areas: Medical Device Design Process, Biocompatibility Testing, Nanotechnology

Bachelor Of Science (Bs), Chemical And Biomolecular Engineering

Activities and Societies: School of Engineering Dean's List | Honors Graduate | President of The National Society of Leadership.