Sarga Gopal C P
A motivated individual with more than 7 years experience in the field of Biomedical engineering. Looking forward to working professionally as a Biomedical Engineer in a stable organization where I could demonstrate my expertise in biomedical products. My endeavor and dedication in the job will be helpful in achieving the company's goals and objectives.
2008-2012 Bachelor of Technology, Specialization:Electronics & Biomedical Engineering, University:CUSAT, College:Government Model Engineering College, Kochi - 682 021. Percentage:63.58, First class
2008 HSC, Kerala Higher Secondary Examination Board, G.H.S.S.Pottassery Percentage:81, Distinction
2006 SSLC, Kerala Board of Public Examinations, H.S.S.Pallikurup Percentage: 90.65, Distinction
2012-2020 Biomedical Engineer
Dynamic Techno Medicals Pvt Ltd, Ashokapuram, Aluva, Kerala - 683 101 Roles And Responsibilities
● Quality Assurance and Regulatory affairs Department from April 2019 to February 2020
Documentation of the Medical Devices including Technical files, Device Master files, Site master files, Clinical evaluation Reports, Biological Evaluation Reports, Risk Management Reports, Essential Principles Checklists etc. Manappadan House, Peruvaram West, North Paravur, Ernakulam, Kerala, India 683513
Documentation of the medical devices for the FDA approval, CE marking And CDSCO Submission.
- Technical Support.
Testing and Demonstration of 3 channel, 6 channel &12channel ECG Machines, Negative Pressure Wound Therapy Machines, Foetal monitors and Foetal Dopplers.
Preparation of operational manuals and quick guides.
Coordination of Telemetry Diagnostic services (Remote cardiac monitoring and Ambulatory BP monitoring services).
Attending Customer complaints and it’s timely resolving.
Coordination of sales and services of the devices.
Coordination of device Maintenance.
Preparation of monthly Reports regarding sales and service.
● Telemetry Diagnostics Division
Incharge of Remote cardiac monitoring and Ambulatory BP monitoring services.
Configuration/Pairing of Remote cardiac monitoring machines and Ambulatory BP monitoring machines according to the patient information received.
Correcting the software errors and solving the issues regarding the live Remote cardiac monitoring.
Report generation from ABPM Machine.
Interaction and coordination with the outside parties like Dealers, Hospitals, Doctors and Patients.
Work Order generation for each case according to the patient details and medical history received from the Doctor/Hospital/Dealer/Patient.
Accurate report delivery to the customers.
Attending Customer complaints and it’s timely resolving.
Coordination of device maintenance.
● ECG Electrode Manufacturing unit from July 2012 to July 2016
Complete Quality Assurance from the Raw materials to the finished Goods.
Mixing and Quality testing of the Conductive Gel.
Experimental studies to improve the conductive gel quality.
SEAM Testing of Electrodes according to ANSI/AAMI EC 12 Standards.
Documentation including Gel mixing Records, RM Test reports, In Process Checklists, SFG, FG & PM Test reports, QP, QPM, SOPs, Batch processing Records, Rejection Reports, CAPA Register, NCR, Despatch records, Documents for the submission of ISO and CE marking audits, Stock registers etc. Manappadan House, Peruvaram West, North Paravur, Ernakulam, Kerala, India 683513
● Medical Equipment Division from August 2017 to March 2019 from July 2016 to July 2017
Stock Handling: RM, IP, SFG, FG & PM.
Coordination of calibration.
Attending Customer complaints and it’s timely resolving. Technical Trainings / Meetings Attended
Attended Training on Usability Engineering as per IEC 62366-1&2 held at Dynamic Techno medicals Private Limited from 18/12/19 to 19/12/19.
Attended Training programme on Medical Device Regulation(EU) 2017/745 implementation course held at Dynamic Technomedicals private Limited from 16/12/19 to 17/12/19.
Attended Training on Quality Management system ISO 13485:2016 held at Dynamic Technomedicals Private Limited in April 2019.
Attended Training on various Medical equipment and its Demonstration conducted at Dynamic Technomedicals in March 2018.
Attended Training on Good Manufacturing Practices held at Dynamic Technomedicals Private Limited
Completed One week Training at the Biomedical department in Ananthapuri Hospitals and Research Institute, Trivandrum from 17/05/10-21/05/10. Positions of Responsibility
In charge of the Telemetry Diagnostic Division at Dynamic Techno Medicals.
Mini Project Team leader at college in sixth semester (2011).
Active member of the Arts and sports events coordination desk at college.
Active Member of the ‘Thanal’ social service activities at college
School leader for the academic year 2006.
Camp leader of the scouts and guides at Rashtrapati workshop for the year 2006
Arts Club Secretary during the Academic year 2005-06.
Worked as a service Guide in the District Level Scouts and Guides camp held in 2006. Extra Curricular Activities
Participated in Technopreneur 2010.
Member of Biomedical Association.
Participate in Excel 2k8,2k9,2k10,a National Level Techno-managerial Symposium
Member of the college arts and sports team.
Actively participated and won prizes in music and literary events at school,College and university level
Won Rajya Puraskar and Rashtrapati Puraskar Awards of Bharath scouts and Guides.
Got ‘Kshethra pravesana vilambaram’ and ‘Thaliru’ scholarships at school level. Manappadan House, Peruvaram West, North Paravur, Ernakulam, Kerala, India 683513 Academic Projects
● Main project of final year (2012): Gait mode recognition of prosthetic leg
It is a device extension that replacing the missing leg part
PIC16F877A is the brain of the arrangement
Application: Help the lower limb deficient person to possess normal locomotion
● Mini project of sixth semester (2011): Automated intravenous infusion system
It is a system which gives automatic administration to intravenous medicine.
Application: It is used to give alert to medical staff during the exhaust of drip bottle.
● Project for College Tech Fest in second semester (2009): Muscular Stimulator
It consists of two parts: IC555 and alarm circuit.
Application: Can be used to give stimulation to the muscles. Technical Skills
Operating System :Windows, Linux
Subjects of Interest : Bio Instrumentation, Telemedicine
Key skills :Quality assurance, Telemetry Diagnostics, Medical Equipment Testing & Technical Documentation.
- Others : ISO 13485:2016, ISO 9001:2008, ANSI/AAMI EC12:2000, QMS Policy, CAPA, NCR, 5S/7S, ERP software.
Excellent Presentation, motivational and leadership skills.
Strong analytical, logical and mathematical skills.
Ability to provide quality knowledge.
Strong Decision making Capability
Ability to work individually as well as in a team
Ability to work under Pressure
I hereby declare that the information furnished above is true and correct to the best of my knowledge.
Manappadan House, Peruvaram West, North Paravur, Ernakulam, Kerala, India 683513