Pin code: 625402
To pursue a highly rewarding career, seeking for a job in challenging and healthy work environment where I can utilize my skills and knowledge efficiently for organizational growth.
1. DyAnsys India Private Limited, INDIA (A Subsidy of DyAnsys Inc. USA):
Duration: Since May 2019
Designation: Design & Development Engineer, Clinical Study Coordinator, Acting Management Representative.
Performed product demonstration of the medical devices under the guidance of product management staff.
Analyzed the application and software related testing(reference standard IEC 62304 ) for the new product development.
Validated continuous testing to ensure medical devices meet the regulatory guidelines and established specifications
Performed validations for product design and identified clinical devices that are in high demand.
Coordinated with surgeons to gather information of the functionalities of the device.
Provided support to R & D department in verifying compliance of product design and manufacturing processes with the project requirements.
Knowledge in the development of class II a Diagnostic medical device and their testing procedures and their improvements stage wise.
Conducting clinical evaluation of products at patient sites and understanding the bugs in detail.Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines
Training junior clinical development engineers in areas of product development.
Preparing documents and guidelines on the technical limitations and operating system manuals. Documentation design files of class 2 devices.
Developing requirement sheets and flow chart to handle the team in new product development of medical devices.
Have wide knowledge on (QMS -ISO 13485, ISO 9001, Electrical Safety-IEC 60601, Risk Management- ISO 14971, Biocompatibility- ISO 10993, Sterilization- ISO 11135, 11138 )related to Medical Device and Medical Device Directives.
Analysing various products in the market and their way of approach,design and features to establish new ideas.
Experience in conducting meetings and video call with higher officials of the management to gather their needs, ideas which acts as a guidance in development of new device.
Achieving and following according to weekly objective and monthly objective so thus to track the lag of the upliftment.
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
Performs additional clinical research functions and assists research team members as required. Coordinates day-to-day project activities, including tracking project requirements, scheduling investigator meetings, and generating meeting minutes.
Independently drafts protocols, Flow chart, standard operating protocols (SOP), amendments and study schedules as appropriate, using proposal and client-supplied information.
Maintaining optimal stock levels to ensure timely availability of products. Managing excess and ageing stock.
Creating and maintaining spreadsheets to report and analyze data. Presenting written reports and analyses to senior managers. Conduct physical count per day & record results in company database.
Inventory maintenance of the New product development items, medical devices and monitoring of the stocks thus updating with regular tracking.
Managing supplier & vendor evaluation, re-evaluation forms and also other department documents such as vendor list maintenance, data analysis.
Performs training evaluation for the all the department staffs and independently manages all the trainings and their schedules.
Have been as Internal auditor in auditing the files thus insuring the improvements and opportunities for all the departments with written audit reports for review and approval.
Registered and Published Clinical study in US National library of Medicine Clinicaltrials.gov and updating ahead.
Currently working in the development of Diagnostic Medical device (Class 2) and the documentation process.
Hands on Training in ECG Monitoring and vital systems.
Have been a part of Internal auditing and auditing evaluation.
Part of the ISO 13485: 2016 Audit (July) held in the organization (2019) .
Part of the EU Recertification Audit 2019 (October) held in the organization.
Part of the FDA Audit 2019 (November) held in the organization.
The ability to empathize with patients.
Communication and team working skills.
Critical thinking and Problem solving abilities (Kepner-Tregoe method)
Software : MSOffice, MS Project,Libre Office, Pages.
Operating System : Windows XP, 7, 8, 10, MAC - iOS 10 and higher.
Under graduation in B.E- Biomedical Engineering with CGPA 7.0 from Agni College of Technology, Anna University (May 2019)
Higher Secondary Certificate (HSC) with an aggregate of 72% from S.D.H Jain vidyalaya higher secondary school, Madurai (April 2015)
Secondary School Leaving Certificate (SSLC) with an aggregate of 92% from Mary Ann Matriculation Higher Secondary School, Madurai (April 2013)
ACADEMIC PROJECT UNDERTAKEN:
Panic Alarm System-Designed to alarm when there is a risk for patient in bed.
Apnea Monitor-Designed to detect apnea in babies.
Skin rash detection through Image recognition using machine learning
AREA OF INTEREST:
Research and development
Gynecology and obstetrics
Organizing events and hosting
Have undergone Internship in Meenakshi Mission Hospital,Madurai (1 week).
Internship for 1 week in Shri Sathya Sai Hospital,Chennai.
Intern in DyAnsys india pvt Ltd since (Dec 2018-Mar 2019).
CONFERENCES & SYMPOSIUM:
Attended a workshop on “Hands on training to handle ultrasound equipments” by Niranjan Ultrasound.
Attended a workshop on “Career counselling & lecture on recent trends in biomedical field.” at Medical equipment expo, SRM University Chennai.
Attended Workshop conducted by SIEMENS healthineers in MRI,CT and Ultrasound equipment
Father’s Name : A.Gunasekaran
Mother’s Name : G.Kavitha
Date of Birth : 23 March 1997
Nationality : Indian
Linguistic Abilities : English & Tamil.
I hereby declare that all the information given above is correct and true to the best of my knowledge and belief.
Place: Chennai Priyadharshini.G