VIGNESH MUTHAN
Pune
Summary
To pursue a highly rewarding career in a challenging and healthy work environment where I can utilize and grow my skills and knowledge efficiently for organizational and personal growth.
Overview
3
3
years of professional experience
Work History
Engineer (Medical Devices)
TATA Elxsi Ltd
Pune
11.2022 - Current
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) preparation as per EU MDR 2017/745 for medical devices (instrument and implant).
- Gap assessment and remediation as per EU MDR 2017/745
- Analysing and identifying the gaps in various biological end-point testing as per ISO 10993 Standards
- Prepare and/or evaluate Toxicological risk assessments, biological evaluation reports in accordance with the ISO 10993
- Toxicology Risk Assessment: Conduct comprehensive toxicological risk assessment as per ISO 10993 Part 17 for Extractable and Leachable derived from medical devices/Materials in Medical devices
- Preparation of Ingredient toxicological profiles as per the regulatory requirements and fill data gaps using read – across, TTC approach, in silico tools (OECD QSAR, Comptox EPA) as per the risk assessment requirements
Scientist (Medical Devices)
GLR Laboratories Private Ltd
Chennai
12.2021 - 11.2022
- Role: Assisting pre-clinical studies for Biocompatibility of medical devices as per the Regulatory guidelines of ISO 10993
- Qualified in performing pre-clinical studies such as short- and long-term Implantation and systemic toxicity studies for Biocompatibility of medical devices as per regulatory guidelines (ISO 10993) as a study personnel GLP studies as of now
- Preparation of Study plan and Study report
- Performing statistical analysis using sigma plot for toxicity studies
- Preparation of study protocol for the appearance of IAEC committees
- Preparation of standard operating procedures and format since compliance with ISO 10993 principles of GLP
Education
M.Sc Integrated - Life Sciences
Bharathidasan University
Trichy, Tamil Nadu01.2020
Higher Secondary Education -
Lakshmi matriculation higher secondary education
Trichy, Tamil Nadu01.2015
Secondary Education -
Lakshmi matriculation higher secondary education
Trichy, Tamil Nadu01.2013
Professionalachievements
- Stellar Contribution Award, 01/01/23, In recognition of the outstanding performance, Contribution, Dedication & Hard work toward the success of the project.
- Customer Appreciation Award, 01/01/24, In recognition for exemplifying excellent contribution to project.
Certificatesandtraining
- Interlinking chemical characterization (ISO 10993-18) & Biocompatibility (ISO 10993-1), GLR Laboratories Pvt Ltd, 07/01/22
- Quality Management System and Internal Audit “ISO/IEC 17025:2017”, Pharmacovigilance Laboratory for Animal Feed and Food Safety (PLAFFS), 06/01/22
Timeline
Engineer (Medical Devices)
TATA Elxsi Ltd
11.2022 - Current
Scientist (Medical Devices)
GLR Laboratories Private Ltd
12.2021 - 11.2022
M.Sc Integrated - Life Sciences
Bharathidasan University
Higher Secondary Education -
Lakshmi matriculation higher secondary education
Secondary Education -
Lakshmi matriculation higher secondary education