Jon Oğuzsimsaroğlu Email & Phone Number

San Diego, California, United States

• Overview: Led the implementation of ISO 80369-7 testing from scratch within 3 months, developing custom equipment and finding creative solutions within the framework of the standard, saving the company nearly $1.
• Designed and fabricated custom fixtures specifically for testing, collaborating with in-house machining teams to ensure precise execution
• Managed the ISO 80369-7 testing for 14 hubs across NATUS brain shunts and external CSF drainage system products, drafting procedures, plans, protocols, and reports while guiding engineers and technicians in executing.
• Took on sustaining activities, including re-sourcing materials and components, performing biocompatibility analyses for discontinued parts, and managing the re-qualification process for replacement materials and.

• Overview: Led R&D efforts on high profile polymeric and metallic Balt products in terms of biocompatibility, compliance with international standards, and Design Verification and Validation activities on old and new.
• Provided mathematical calculations and proofs where applicable to justify that no further testing or re-testing is required, saving the company months as well as tens of thousands of dollars, utilizing standards such.
• Overhauled documentation regarding product specifications, drawings, risk management, post market surveillance to comply by the harmonized standards dictated by the Medical Device Regulations (EU). Wrote 15+ test.
• Improved company QMS by writing SOPs for usability, product specs as well as developed test methods for new products.
• Optimized existing test methods by eliminating inaccuracies. Performed feasibility testing & DVV for a new product line
• Trained 10+ new engineers and technicians to numerous SOPs and test methods to help in MDR compliance efforts

Durham, North Carolina, United States

• West Lab
• Overview: Led the project to treat myocardial infarctions resulting from heart attacks, using a light-activated infarction homing nitric oxide releasing nanoparticle injection system.
• Researched 15+ unique formulations of nanoparticles regarding activation mechanism, homing mechanism and nitric oxide (NO) release mechanism to identify the combinations with most success.
• Constructed a unique nanoparticle consisting of cupferron modified gold nanoparticle with PEG and platelet membrane that would target ischemic myocardial cells and get activated by IR light to release NO.
• Wrote protocols and performed preliminary studies on immune system bypassing and selective homing abilities of the final nanoparticle. Confirmed the amount of NO released would be effective to treat myocardial.
• Overview: Led the project to identify an injectable MMP cleavable cross-linked biomaterial that would homogeneously polymerize at the target location to treat internal bleeding and induce rapid healing by supporting an.

Warsaw, Indiana, United States

• Lead remediation efforts on 5 high profile Design History Files (DHF) of medical devices to ensure FDA regulatory compliance regarding Design Verification & Validation.
• Resolved biocompatibility issues for 200+ DHFs by proposing the usage of biomaterial leeching rate for the instruments and implants of the highest contact area, saving 24,000 engineering hours
• Lead product design review meetings, closing the gap between user needs and design constraints for 300+ implants/instruments.
• Onboarded and trained 15+ development engineers to assist with remediation effort.
• Performed functional relationship analyses of instruments and implants utilizing Unigraphics CAD software.
• Wrote protocols to test implants utilizing electrical sensors for design validation.

Providence, Rhode Island Area

• Working in product development, specifically on diffusion of molecules throughout. Researching about unique and innovative ways in order to improve device properties.My achievements within this job were:
• Proposed a base material and coating combination that was used in the final stages of development.
• Conducted insulin/oxygen diffusion experiments to determine successful membrane and coating combinations using different molecular weight markers to ensure device’s functionality as well as immunoprotective capacity.
• Determined medical device target implant location within the body for maximum oxygenation and connection to circulation
• Improved Semma’s sampling methodology, thereby drastically improving the quality and reproducibility of data.
• Used finite element analysis to mimic insulin/oxygen diffusion of the device within the human body to ensure encapsulated cell survival.

Ithaca, New York Area

Performed PCR, gel electrophoresis and DNA sequencing on Angiostrongylus vasorum species which were extracted from infected gastropods' foots with the usage of pepsin.Performed an epidemiological experiment using infected gastropods (snail) and also wrote an epidemological review paper on different species of Angiostrongylus in the Americas

Master Of Science - Ms, Bioengineering And Biomedical Engineering, 4.0

Activities and Societies: West Lab and Segura-Yuan Lab memberSpecialized in biomaterials and drug delivery

Bachelor Of Science (B.S.), Bioengineering And Biomedical Engineering, 3.8