Brad Dworak Email & Phone Number

Gaithersburg, Maryland, United States

I direct the development of next generation mobile wireless communications by engineering advanced AI-capable accelerated system platforms.

Silver Spring, Maryland, United States

𝗜 𝗽𝗿𝗼𝘁𝗲𝗰𝘁 𝘁𝗵𝗲 𝗨𝗦 𝗽𝘂𝗯𝗹𝗶𝗰 𝗯𝘆 𝗵𝗲𝗹𝗽𝗶𝗻𝗴 𝘁𝗼 𝗲𝗻𝘀𝘂𝗿𝗲 𝘁𝗵𝗮𝘁 𝗙𝗗𝗔-𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗮𝗿𝗲 𝗱𝗲𝗺𝗼𝗻𝘀𝘁𝗿𝗮𝘁𝗲𝗱 𝗮𝘀 𝘀𝗮𝗳𝗲 𝗮𝗻𝗱 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲. 𝗜 𝘀𝗲𝗿𝘃𝗲 𝗼𝗻 𝘁𝘄𝗼 𝗔𝗿𝘁𝗶𝗳𝗶𝗰𝗶𝗮𝗹 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲𝘀 𝘁𝗼 𝗳𝗼𝗿𝗺 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲𝘀 𝗳𝗼𝗿 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘄𝗶𝘁𝗵 𝗔𝗜 𝗰𝗼𝗺𝗽𝗼𝗻𝗲𝗻𝘁𝘀. 𝗜 𝗵𝗮𝘃𝗲 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗶𝗻 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗿𝗲𝘃𝗶𝗲𝘄 𝗮𝗻𝗱 𝗼𝗻-𝘀𝗶𝘁𝗲 𝗶𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝘀𝗶𝘁𝗲𝘀 𝗮𝗻𝗱 𝗮𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲𝗱 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝘀𝘆𝘀𝘁𝗲𝗺𝘀.• Lead reviewer and chairperson of 15 biological product license applications (BLAs). Objective of review is to assess the Chemistry, Manufacturing, and Controls (CMC) information for approvability.• Certified as FDA Lead Inspector. Created project plans for comprehensive review of: Pharmaceutical Quality Systems (PQS), Quality Management Systems (QMS), Quality Assurance (QA), Quality Control (QC) testing, data integrity, continuous process improvement, trending analysis, and IT management systems.• Contributed as subject matter expert (SME) for over 50 applications in total including 6 original BLAs, Emergency Use Authorizations (EUAs), Drug Master Files (DMFs), 510(k)s, and PMAs. Recommendations for approval were based on sound judgment and compliance with Good Manufacturing Practice (GMP) regulations including: process validation and verification, aseptic processing technique, and benefit/risk analysis.

𝗜 𝗿𝗲𝘃𝗶𝗲𝘄𝗲𝗱 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗿𝗲𝗽𝗼𝗿𝘁𝘀 𝗼𝗳 𝗙𝗗𝗔-𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗻𝗲𝘂𝗿𝗼𝘀𝘂𝗿𝗴𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝘁𝗼 𝗵𝗲𝗹𝗽 𝗲𝗻𝘀𝘂𝗿𝗲 𝘁𝗵𝗲𝘆 𝗮𝗿𝗲 𝘀𝗮𝗳𝗲 𝗮𝗻𝗱 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗳𝗼𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝘂𝘀𝗲 𝗼𝗻 𝗨𝗦 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀. 𝗜 𝗵𝗮𝘃𝗲 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗶𝗻 𝗿𝗶𝘀𝗸/𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗮𝗻𝗱 𝘀𝗼𝘂𝗻𝗱 𝗷𝘂𝗱𝗴𝗺𝗲𝗻𝘁 𝗼𝗳 𝗰𝗼𝗺𝗽𝗹𝗲𝘅 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗱𝗮𝘁𝗮 𝗮𝗻𝗱 𝘀𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝘀.• Lead Reviewer of 110 submissions including 510(k)s and IDEs of neurosurgical devices. Recommended approval based on sound judgment and critical analysis of benefit/risk and supporting safety and efficacy data including: technical performance, design engineering, and software.• Directed multidisciplinary teams and committees to negotiate and resolve complex issues by engaging in interactive meetings between FDA management and engineers, legal representatives, and industry stakeholders.• Presented technical insight and regulatory history of medical devices including industry standards, design controls, and legal precedence.

𝗜 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗲𝗱 𝟯 𝗶𝗣𝗵𝗼𝗻𝗲 𝗶𝗢𝗦 𝗺𝗼𝗯𝗶𝗹𝗲 𝗮𝗽𝗽𝘀 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗔𝗽𝗽 𝗦𝘁𝗼𝗿𝗲 𝗳𝗼𝗿 𝘄𝗼𝗿𝗹𝗱𝘄𝗶𝗱𝗲 𝗱𝗶𝘀𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻. 𝗜 𝘄𝗮𝘀 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗹𝗲 𝗳𝗼𝗿 𝗮𝗹𝗹 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝘁𝗵𝗲𝘀𝗲 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗱𝗲𝘀𝗶𝗴𝗻, 𝘂𝘀𝗲𝗿 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲, 𝗴𝗿𝗮𝗽𝗵𝗶𝗰𝘀, 𝗰𝗼𝗱𝗶𝗻𝗴, 𝘃𝗲𝗿𝘀𝗶𝗼𝗻 𝗰𝗼𝗻𝘁𝗿𝗼𝗹, 𝗮𝗻𝗱 𝗰𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗼𝗳 𝗮𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲.

𝗜 𝗺𝗮𝗻𝗮𝗴𝗲𝗱, 𝗱𝗲𝗹𝗲𝗴𝗮𝘁𝗲𝗱, 𝗮𝗻𝗱 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗲𝗱 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗿𝗲𝘃𝗶𝘀𝗶𝗼𝗻𝘀 𝘁𝗼 𝘁𝗲𝗮𝗺 𝗺𝗲𝗺𝗯𝗲𝗿𝘀 𝗶𝗻 𝗮 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗲𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗺𝗮𝗷𝗼𝗿 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗮𝗹𝗴𝗼𝗿𝗶𝘁𝗵𝗺 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀 𝗼𝗳 𝗺𝘆 𝗼𝘄𝗻. 𝗜 𝗵𝗮𝘃𝗲 𝗴𝗮𝗶𝗻𝗲𝗱 𝗲𝘅𝗰𝗲𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗶𝗻 𝘀𝗮𝗳𝗲𝘁𝘆-𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝘀𝘆𝘀𝘁𝗲𝗺𝘀, 𝗰𝗵𝗮𝗻𝗴𝗲 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁, 𝗮𝗻𝗱 𝘀𝗮𝘁𝗲𝗹𝗹𝗶𝘁𝗲 𝗻𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗼𝗻.• Analyzed the technical performance and capabilities of the Wide Area Augmentation System (WAAS), a safety-critical navigation system that augments GPS, known as the Global Navigation Satellite System (GNSS).• Developed software algorithms to enhance satellite positioning, orbit determination, and geodetic observations. • Served as an Agency point of contact (POC) for mission support, program coordination, and knowledge transfer from contractor support to FAA in-house operations and maintenance.• Demonstrated independent leadership and change management skills in an IT Agile team environment working with research groups by delegating, planning, and monitoring revision tasks.

Gainesville, Florida, United States

• Computer aided design (CAD) and manufacture of micro-electro-mechanical-systems (MEMS) semiconductor devices

• MEMS manufacturing of multi-electrode arrays (MEAs) including statistical analysis (SAS) of bioactivity of neurons.

Doctor Of Philosophy - Phd, Electrical And Electronics Engineering

Bachelor Of Science - Bs, Electrical And Electronics Engineering