Hamza Ahmed

**** *********** ** #*** *******, TN 38125 901-***-**** adld6g@r.postjobfree.com

Summary Biomedical Engineering graduate with research and internship experience, seeking full-time opportunities in the medical device industry.

Education University of Memphis, Memphis, TN

Bachelor of Science in Biomedical Engineering

Graduated December 15, 2019

Experience

Regulatory Affairs Specialist II APAC; Contract Cook Medical Inc.

Bloomington, IN. June 2020- Present

•Served as a liaison between Cook Inc’s engineering and remediation teams to assist with regulatory submission pathway for markets in the Asia Pacific region to seek marketing approval for Cook Medical’s aortic intervention device families.

•Analyzed internal documentation to determine gaps between various medical device design history file (DHF) documents and requirements of the local regulatory bodies in Korea, China and Japan.

•Communicated region specific regulatory requirements to the Regulatory Science team leaders and assisted with the formation of regulatory strategies.

•Prepared regulatory submissions for new products, product changes, and re-registrations as required for the specific regions.

•Maintained and organized appropriate regulatory records to demonstrate compliance with applicable regulations.

•Maintained registration information (license numbers, expiration dates, etc.) in the appropriate Cook medical systems and obtained re-registration in advance of license expirations to ensure the product availability is not disrupted.

Post-market Surveillance Engineering Intern, MicroPort Orthopedics

Arlington, TN September 2018-August 2019

•Developed a VBA macro for the PMS group which made mass medical literature look-up efficient, this made retrieving data for Clinical evaluation report (CER) writing and Post market surveillance (PMS) reviews more efficient.

•Compiled a literature database for past CER and PMS reviews to support marketing and PMS for all company products that were published in literature.

R&D Intern, Applied Research in Biomechanical testing, Medtronic Spine and Biologics

Memphis, TN. May 2018-August 2018

•Facilitated mechanical testing for novel spine interbody fusion devices, instruments, and screw and rod constructs following ASTM standards for spinal mechanical testing.

•Operated hydraulic and electromechanical test frames using lab safety protocols to evaluate static and fatigue behavior of implants and instruments in terms of stiffness, ultimate load, yield load and cycle to load relationship (F-N).

•Designed test fixtures to allow for non-ASTM standard tests to be conducted using CREO to model part drawings.

•Created log sheets, captured pre and post-test pictures, inspected parts for fatigue crack propagation.

•Prepared lab reports for 3 levels of testing including design feasibility, data only, and design verification.

•Performed other various lab maintenance and housekeeping tasks such as inventory, ordering hardware, and fixing minor lab equipment.

Regulatory Affairs Intern, Medtronic Spine and Biologics

Memphis, TN. January 2018-May 2018

•Global medical device company focused on spine implants for anterior cervical discectomy and fusion as well as total disk replacement tools, biologics and implants. Worked on building a MDR design dossier template, analysis included gap analysis due to changed MDR regulations.

•Compiled a parts list which ultimately helped to determine obsolescence in changed EUMDR requirements.

•Worked on monthly newsletter regarding changing requirements as well as analyzing whether applicable NCR from corporate apply to any product families in the business unit.

Research Assistant, Biomedical Engineering Department, The University of Memphis

Memphis, TN. May 2016-January 2018

•Assisted in the research on a polysaccharide biomaterial called Chitosan for wound care applications and local delivery of proteins, antibiotics and chemotherapeutics.

•Worked on the degradation profile of chitosan-PEG DMA 500 magnetic nanoparticles in vitro, which eventually was published in an international journal.

Skills

•Proficient with Microsoft Office

•Knowledgeable of MatLab, LabView, Thermofisher HPLC, SigmaPlot, Siemens NX 12.0

•Proficient at operating electromechanical and hydraulic test frames

•Excellent presentation and technical writing skills

•Outstanding project planning, management and execution capability

Activities, Honors, & Awards

•Placed 1st in the annual Student Research Forum poster presentations at the University of Memphis

•BMES-SFB Member – University of Memphis Chapter

Publications

1.Harris, M., Ahmed, H., Barr, B., LeVine, D., Pace, L., Mohapatra, A., Morshed, B., Bumgardner, J.D. and Jennings, J.A., 2017. Magnetic stimuli-responsive chitosan-based drug delivery biocomposite for multiple triggered release. International journal of biological macromolecules, 104, pp.1407-1414.

2.Harris, M., Ahmed, H., Pace, L., Minter, J., Neel, M. and Jennings, J., 2018. Evaluation of Antibiotic-Releasing Triphasic Bone Void Filler In-Vitro. Journal of functional biomaterials, 9(4), p.55.

Presentations

• Presented a joint study performed with Osteoremedies® on the off-label effects of antibiotic incorporation in triphasic bone void filler at the annual Musculoskeletal infection society (MSIS) 2017 scientific conference.

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