Jimit Rathod

****N Bonnie Brae St, Denton, #**** USA 76207 940-***-**** ad4ijk@r.postjobfree.com Objective:

Dedicated Biomedical Engineer with experience in medical device industry seeking Full-time opportunity. Education:

M.S in Biomedical Engineering, University of North Texas Dec 2023 Relevant Course works: FDA Device Regulations and Quality control, Biomedical Engineering Laboratory, Biopolymer and flexible Bioelectronics, Biomaterial compatibility, Medical Imaging, Bio MEMS, Medical Implant, Bio Nano technology, AI fundamentals, Marketing of Health care services, Health Services Administration. Work Experience:

Steris, Conroe, Texas, Engineering Intern Sep 2023 – Dec 2023

Worked toward design change in existing medical devices, 510 (k) submission and 510(K) deficiencies.

Worked with Product Quality & QMS, ISO 13485, FDA 21 CFR 820, Risk Management, Change control.

Complaints handling of class -2 medical devices. Monitor, implementation, and effectiveness of CAPA.

Develop and Execute test protocol (feasibility) and analyze the test results. Documentation of (DDP, DHF, DMR) compliance with the FDA regulations. Assist in Internal Audit, 5S Audit, FDA Audit, Kaizen.

Assist with regulatory compliance (FDA, EU-MDR) of medical devices. University Of North Texas, Denton, Texas, Research Assistant Dec 2022 – July 2023

Assist with designing and testing the efficacy of Biomimetic Human Lung on chip system.

Collect and analyze data using R, Solid works, Electrospinning, 3D printing, cell culture.

Collaborate with team members and Maintain laboratory equipment and supplies, microfabrication. American Red Cross, North Texas, Volunteer March 2022- present

Blood management, manage blood drive, provide excellent support to the blood doner and medical assistants. Project Experience:

Design change in class-2 Medical Device (FDA approval follow up) Fall 2023 Biomimetic Human Lung on chip system for the diseased lung analysis Spring 2023 Skills:

knowledge of FDA Regulations and Quality control (GMP, MDR, PMS), ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR (Part -7,801,803,807,820,211), Regulation (EU) MDR 2017/745, MDSAP, GLP, Project Management, Product Life cycle Management, Lean Manufacturing, Clean Room (class 7) operations, ASTM.

Proficient in SolidWorks, MATLAB, Python, R, C, C++, Image J, MS office, Minitab (inferential statistics T- test, one- way Anova), Reliability engineering (tolerance interval, K-factor analysis, Weibull distribution).

Familiarity with laboratory (BSL-1,2) instruments and procedure fume hood, chemical hood, Biosafety cabinet, Microscope, micro fabrication techniques, electrospinning, injection molding, tubing extrusion, spin coating, 3D printing.

Certifications:

Certified First AID (CPR, AED), First AID for Severe Blood Trauma Provider, American Red Cross.

Food handling license (Texas state).

Working toward Certified Quality Engineer (ASQ), EU MDR regulation certification, and a Certified SolidWorks expert.