Brad Gould Email & Phone Number

Evanston, Il, Us

North Chicago, Illinois, Us

Responsible for providing program leadership to identify drug delivery technologies and partners from feasibility through launch. Collaborate with internal stakeholders to identify solutions which meet AbbVie’s needs. Conduct applied research/landscaping of drug delivery platforms, and lead global programs with goal of enabling the asset pipeline.

North Chicago, Illinois, Us

R&D Device lead for platform combination product delivery system landscaping, assessment, and translational development. Led multiple clinical and platform global programs to build framework for enabling of drug asset pipeline. Worked with asset teams and served as liaison with external partners to frame strategy for platform and asset program deployment and execution.

North Chicago, Illinois, Us

R&D lead for next generation infusion pump cassette for percutaneous gastrostomic delivery of Duopa for treatment of advanced Parkinson's disease. Responsible for management of cassette design and R&D team, cross-functional communications, device verification, risk management, and transfer of product to high-volume manufacturing at overseas facility.

● Consulting early stage medical device startup in the areas of product development and quality/regulatory for commercialization of cancer screening technology ● Provide project management for commercialization plan

Evanston, Il, Us

● Continuation of research and development activities as defined in American BioOptics description below ● Management of all system and probe development and implementation related activities in support of multi-site clinical trials ● Management of second generation LEBS system and probe design and clinical release for pilot clinical trial ● Co-wrote as co-Principal Investigator on submitted NIH SBIR grant application

Chicago, Il, Us

● Company licensed technology application to an undisclosed global medical device company in 12/2010 ● Project lead for development, design definition, and design implementation of optical backscatter probes and the mechanical portion of system for cancer screening and diagnosis ● Interaction with physicians and optical engineers to define probe mechanical design requirements, components, and method of use ● Management of the design and implementation of probe concepts for clinical evaluation ● Definition and management of outsourcing for manufacture of both the probe and mechanical portions of the system ● Development of project goals, schedules, budgets, and resources ● Management of quality and regulatory aspects related to probe and system development, including hazard tracing, requirements management, and verification/validation testing ● Composition of grant proposals and summary reports ● Assisted in FDA QSR implementation and ISO 13485 quality certification (Certification received in 01/2010) ● Supported European market approval process for optical system and probe (CE marking of class IIa device received in 01/2010)

Libertyville, Illinois, Us

● Design and development of obstetric devices, breast pumps (both institutional and retail), and disposable breast pump accessories ● Analysis of marketed product deficiencies and implementation of product improvements

Lake Forest, Il, Us

● Design and development of disposable and electro-mechanical components and systems for critical care medical devices ● Generation of concepts/designs to meet device objectives (i.e. product performance, manufacturing, human factors) ● Creation of analytical models and test methodologies to assess/select/validate design options ● Design modeling, development, testing, and documentation of mechanical parts including tolerance and part stack-up analyses ● Project-engineering responsibilities such as time and cost estimates, risk assessment, and contingency plan development ● Main projects included: 1) Central Venous Oximetry Probe with Fluidic Seal (FDA approval as class II device in 08/2006), and 2) Antimicrobial Clave (luer-access) Valve (FDA approval as class II device in 04/2009).

North Barrington, Il, Us

● Medical device product design and development ● Concept review and selection, material selection, solid modeling, prototype assembly/testing, formulation of assembly procedures and relating documents ● Main project: Contract to CryoCath LLC for feasibility development of cryoablation balloon probe for treatment of atrial fibrillation - device later received FDA approval and acquired/currently being sold by Medrontic as "Artic Front"

Deerfield, Illinois, Us

● Support for re-design of peritoneal dialysis transfer set disinfection methodology ● Allocation of materials and engineering incorporation of antimicrobial into existing product ● Design of testing protocol and completion of experimental evaluation ● Project used for completion of thesis for M. Eng. degree at UCSD

M.Eng., Bioengineering

B.S., Mechanical Engineering