Engineer Quality

VENKATESWARAN GANESH

***********@*****.*** +1-317-***-****

SUMMARY: With a demonstrated expertise in engineering and a passion for research, seeking an opportunity as Quality Engineer. Experienced with statistical analysis and trained in medical devices with working knowledge of FDA/ISO regulations and a skilled researcher with great analytical, problem-solving skills. Highly systematic in thought process. Authorized to work in USA and willing to relocate.

SKILLS: LabVIEW, MATLAB, Tableau, SAS, CREO Parametric, SolidWorks, Minitab, Multisim, LIMS, EndNote, Six Sigma, good understanding of selected ICH-GCP, cGMP, ASTM, ISTA, ISO and FDA standards (for medical devices), Immuno-histological techniques, animal model handling, cell and tissue culturing, ELISA, micro-CT, ImageJ, Microsoft Office (Word, Access, Excel, PowerPoint, Publisher, Outlook, Movie maker) and Google (Docs, Slides).

EDUCATION

Master of Science- Biomedical Engineering Purdue University, Indianapolis May 2018

Related coursework: Advanced biopolymers, Applied Mathematics for Scientists & Engineers, Drug delivery, Cancer biology, Vascular biomechanics, Endocrinology, Musculoskeletal biology Inter-professional Experience (coordinated with medical professionals for three separate healthcare projects), BME design (FDA; 21 CFR Part 800-1,3,5,7,8,9,10,12,14,20,21,22,30,61,64,70,80,88, ISO standards; 13485, 14971, 17025 for biomedical industries)

Bachelor of Engineering- Biomedical Engineering Anna University, Chennai May 2015

Related coursework: Hospital management, Diagnostics and therapeutic equipments I & II, Electronic circuits, Physiological modelling, Biocontrol systems, Analog and digital integrated circuits, Data Structure and OOP, Biochemistry, Anatomy and Human physiology, Biomaterials and artificial organs and Medical physics

EXPERIENCE

Graduate Teaching Assistant Department of Biomedical Engineering Aug 2016 – Dec 2016

Covered principles of fluid mechanics & biomechanics of human circulation with mechanical analyses (Biofluid & solid mechanics)

Delivered a range of teaching and assessment activities including tutorials directed towards the topic addressed.

Held regular office hours and coached undergraduates; evaluated, graded assignments and examinations.

Biomedical Engineer RENMED India Pvt Ltd, India Jun 2015 – Jun 2016

Evaluated the safety and effectiveness of medical equipment and provided technical support for medical devices serviced and installed following CA/PA protocols. Performed V&V tests and filed case report forms.

Played the role of application specialist in-charge of endoscopic and laparoscopic surgical instruments and equipments.

Ensured regulatory compliance with respect to validation and process change control through evaluation and auditing of current procedures followed by documentation.

Prepared, maintained, and reviewed validation and compliance documentation with IQ/OQ/PQ

Maintained medical records, regulatory documents and filed case report forms and participated in the review and installation of technology products and equipment.

Worked with the project teams to define and create verification/ validation planning and procedures.

PROJECTS

Inter-Professional Experience (Certified by Interprofessional Practices and Education Center, IUPUI):

oLead a team of healthcare professionals to develop a pioneer twenty-four-month intervention program to manage weight loss, using evidence-based peer coaching model. Developed online survey to collect feedback, analyze using Minitab to design the appropriate solution model. (April 2018)

oDesigned and developed a one of a kind facilitator’s guide to educate kindergarteners about substance abuse and statistically verified its success. (Nov 2017)

oCollaborated to develop a complete group-focused prenatal care for opioid addicted mothers, pre- and post-partum, in the state of Indiana by performing data collection and analysis in hospitals and recovery centers. (Mar 2017)

Pharmacokinetic modelling: Developed a physiologically based pharmacokinetic MATLAB model for a butyrate drug (HQK1001) and Regadenoson used to treat sickle cell disease and verified the results with PK-Sim by Bayer. (April 2017)

Fluid biomechanics: Examined the role of low and high wall shear stress during atherosclerotic plaque development and progression by modeling the vessel using SolidWorks (Dec 2016)

Bioinstrumentation:

oDesigned an electrocardiogram (ECG) controlled pacemaker stimulator kit for teaching purposes (May 2015)

oDesigned a highly-efficient electro-magnetic energy harvesting circuit (EMEH) to test the shielding of a pacemaker from radio-frequency interruptions up to 2000MHz with a conversion efficiency of 98% (May 2014)

oDesigned and implemented a JAVA based web application expert system for first aid care to provide statistical medical evaluation to the students using SAS. (Dec 2013)

oDesigned the components of a cost-efficient air flow detection system for a ventilator circuit kit using PTC CREO parametric software (May 2013)

INTERNSHIPS

Medical Auditor, Apollo First Med Hospital, Chennai, India (June 2014)

(Performed preventive maintenance, and filed audit reports by shadowing Chief Medical Auditor after inspection of medical/laboratory devices and working standards)

Biomedical Engineer, Apollo Hospital, Greams road, India (June 2013)

(Involved in regular biomedical engineer activities in the hospital. Assisted in evaluating and provided inputs for an in-house Pulse oximeter which was under development by verifying the 3D design layouts using Solidworks software.)

PUBLICATION

Authorship Trends Over the Past 30-Years in the Annals of Biomedical Engineering; ABME, Springer Publication.

ORAL/POSTER PRESENTATION

Pain Management During Space Mission: A Transcriptomic Study Using Brain Tissues Obtained from NASA/Rodent Research 4 (RR4) program. (ORS Great Lakes/Midwest Regional Symposium, UoM Ann Arbor, 2018)

Minimally Invasive, Non-Terminal In-Vivo Muscle Testing of a Porcine Tibia Fracture Model (IUSM, 2018)

Evaluation of a Critical Sized Bone Defect in a Porcine Tibial Model (ORS & IUSM. 2018)

Footwear Design for Diabetic Patients using Plantar Pressure and Gait Analyses using CREO Parametric. (National

Biomedical Sleep Inducer for Neonatal Application. (National Level Technical Symposium, Srishti 2k12, 2012)

CERTIFICATION

Interprofessional Integrative Experience (three inter-collaborative healthcare projects) Interprofessional Practice and Education Center, Indiana University, 2018.

IUCAC, 2018.

REFERENCES: On request

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