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..
• 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.
• 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.

• 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.
• 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.
• 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.
• 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