ELAKKIYA JAYARAMAN

Sewickley, PA ***** 412-***-**** adhp0i@r.postjobfree.com https://www.linkedin.com/in/elakkiya-j/ EDUCATION

Master of Science, Biomedical Engineering (GPA: 3.63/4.0) June 2020 State University of New York at Buffalo, Buffalo, New York Bachelor of Technology, Biomedical Engineering (CGPA: 8.32/10.0) May 2018 Sathyabama Institute of Science and Technology, India KNOWLEDGE AREA & SKILLS

• Microbiology • Minitab, SPSS • cGMP • GDP

• Cell Culture • ISO 13485 • ISO 14971 • SPC

• CAPA • FDA regulations • FMEA • Prototyping

• MS OFFICE • Aseptic techniques • Analytical technique • IQ, OQ, PQ EXPERIENCE

Biomedical Engineering Intern-MEDFREE Inc, Fremont, California August 2020-Present

• Assisted in the product development and prototyping of class III vascular device and associated delivery catheter.

• Co-authored standard protocols for pre-clinical evaluations, clinical and early feasibility testing for the device.

• Managed R&D deliverables for FDA submission including Breakthrough Device Designation(BDD), Pre-Submission and grant submissions(NIH).

• Prepared technical documentation Quality manual, Design control, risk management to ensure audit readiness for FDA activities.

• Interfaced with customers( cardiologists, patients) to identify critical parameters to optimize & improve designs. Project manager, Engineering Intramurals, Buffalo, New York January 2020-June 2020

• Managed a group of 3 undergraduate students (interdisciplinary) at the University at Buffalo as a part of 12-week project.

• Implemented a deliverable oriented approach to ensure efficiency and on-time delivery of project goals using agile methodologies.

• Maintained documentation and reports using JIRA and Confluence software throughout the project timeline.

• Scheduled and organized meetings to ensure team collaboration and project progress using MS Project. Graduate Student Researcher-Ehrensberger Orthopedic Research Group, Buffalo, New York June 2019-June 2020

• Evaluated the efficacy of a novel medical device used for biofilm control and prevention on Orthopedic implant materials.

• Development of protocol for assessing the effects electrochemical stimulation of implant materials following Good Laboratory Practice.

• Used analytical instruments such as SEM, Spectrophotometer, HPLC, pH meter, UV-Vis, FTIR to quantify results.

• Routine usage of lab equipment in a level 2 Bio safety lab in the University following EH&S, OSHA guidelines. Intern-Apollo Hospital, Chennai December 2016-January 2017

• Performed preventive maintenance, calibration and qualification testing according to ISO and NABH standards to ensure electrical and quality standards of Class 1 & 2 medical devices.

• Compilation of records of medical device to ensure accuracy, reliability of the records and ease of access using CMMS. PROJECTS

Antibacterial activity of microenvironment pH on Titanium coupon-based Methicillin-Resistant Staphylococcus Aureus June 2020

• Investigated the antimicrobial property of medium alkalinity by utilizing microbiology techniques including cell culture.

• Documented a standard operating procedure to determine the efficacy of control and experiment groups within 5% accuracy and identified key working factor in the treatment model.

• Summarized the differences and similarities between different methods to facilitate understanding of parameters influencing various modalities by statistical analysis of the data using SPSS. Wearable technology for detection of migraine symptoms in individuals.

• Proposed a study to develop an innovative, wearable sensor to accurately detect and evaluate pre-migraine symptoms to increase understanding and treatment of the disorder.

• Developed an application to display real time information of detected biological changes in a smart phone. Assessment of Morphological changes of the single bovine endothelial cell exposed to electrical stimulation using Image Analysis algorithm December 2018

• Developed an algorithm in a clinical setting to mitigate image noise to obtain cell image data from raw data.

• Calculated the significant variation between baseline image and experimental image by employing MATLAB functions.

• Leveraged statistical tools to record, analyze and export for error detection.