Benjamin Horelik

**** ******** *****, ********** ** 22314 • 508-***-**** • ac8oln@r.postjobfree.com

Career Summary

Biomedical and electrical engineering education with intellectual property experience and regulatory affairs training; additional skills in programming, software, and medical knowledge.

Education

The George Washington University, Washington DC

Master of Engineering: Regulatory Biomedical Engineering (rBME) May 2019

Practicum: Prosthetic Dental Implant with Integrated Drug Delivery and Osseointegration Means

●Wrote a 510(k) submission for a novel dental implant, and identified predicate devices, produced comprehensive labeling, and compiled appropriate FDA safety milestones for biocompatibility, shelf life, and sterilization as per published ISO and FDA standards

●Wrote a mock SBIR / STTR Phase I Grant to explore additional clinical research considerations for the above dental implant, specifically to investigate bioavailability and toxicity, optimal design parameters, and quantify the growth rate of cancellous mandibular bone

●Successfully designed several medical implants according to FDA regulations relating to biocompatibility, mechanical stress, corrosion, and osseointegration, and compiled preliminary information for FDA filing in regards to product codes and predicate devices

●Assessed regulatory strategy as it relates to device safety and complexity, in order to determine appropriate class and related submission requirements

●Completed coursework relating to mechanics and considerations for 510(k), PMA, and de novo submissions, and associated supplemental filings

●Reviewed RPM and 21 CFR to determine applicable penalties for non-compliance, and strategies to bring engineering and manufacturing departments into compliance

Bachelor of Science: Biomedical Engineering May 2013

●Created a handheld iOS A-mode ultrasound system to image and diagnose eye diseases and anomalies, and display with an App in an iPad

●Led and coordinated subsystem integration for commercialization in military personnel and field use

●Ensured that the device met FDA regulations regarding heat generation and electrical safety

Work Experience

Quality Assurance Lead - CPA Global, Alexandria VA August 2017 - Present

●Manage medical device patent casework delegating assignments among a team of 10 analysts, to perform patent examination duties for the United States Patent and Trademark Office, specifically on medical and biotechnology patents in the fields of prosthetics, image analysis, diagnostic devices and software, and instrumentation

●Correspond with the USPTO regarding case submissions and ongoing discussion of technical considerations for patent examination, in order to document trends and incorporate USPTO feedback in general patent examination workflow

●Review analyst casework for technical accuracy, ensuring submitted examination reports meet USPTO requirements of Novelty and Non-Obviousness

●Educate analysts on applying engineering concepts as they relate to claimed medical devices, resulting in increased case production volumes per month

●Conduct patent searches to evaluate claimed medical technology as compared to industry standards

Patent Analyst - CPA Global, Alexandria VA November 2014 - August 2017

●Performed prior art search and analysis on new PCT cases by interpreting claim language and identifying the inventive engineering concepts

●Researched existing patent landscape using patent family databases truncated with keywords and Boolean operators

●Wrote rejections and/or allowances on PCT claims based on the found prior art, using references and non-patent literature from scientific journals and university research

Patent Classifier - KT Consulting, Harrisonburg VA June 2013 - November 2014

●Analyzed patent device applications for diagnostic medical devices, surgical instruments, and prostheses

●Determined appropriate classification in USPC Schedule using rules and guidelines of the United States Patent and Trademark Office

Electrical Engineering Intern - A123 Systems, Westborough MA Summer 2012

●Performed Root-Cause Analysis and implemented solutions for different failure modes in a Lithium-Ion 13V battery pack relating to hardware design and software features

●Executed a report on extensive testing and research on battery life and performance, guiding identification of new markets

●Recommended manufacturing protocol modifications reducing inefficiencies and saved the company an estimated $300,000 per year

Skills

Programming Languages: C, Mathematica

Database Searching: PatBase, Orbit, ProQuest, PubMed, Engineering Village

General Medical knowledge regarding: Medical Imaging > Surgical Instruments > Medical Diagnostics >Prostheses > Bio-materials > Ocular diseases

Software: Microsoft Office Suite > LabView > MATLAB > PSPICE > HyperTerminal

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