SATHISHKUMAR THIRUNAVUKKARASU
Biomedical Engineer, QA & RA Specialist, R&D Sustenance Engineer
Pune, Maharashtra, India 61, Dharmalingeswarar Nagar, Thaayarkulam,
Kanchipuram – 631501, Tamilnadu, India.
SKILLS
Technical Skills
 Biomedical Instrumentation
 Medical Device Repairing & Maintenance
 Product Development (Hardware & Software)
 Biomedical Signal & Image Acquisition
Methods and its Processing techniques
 Medical Device Regulations (EU-MDR & FDA)
 SaMD
 Medical Device - R&D, Packaging & Labelling
- Updating Packaging Drawings, DV Reports
 Medical Device Technical Documentation
Preparation & QA Review
- DoC, IFU, Standard List, RMR, GSPR &
Standard Assessments, Packaging DV Reports
 Medical Device Standards Assessments
- Biocompatibility (ISO 10993 Series)
- Packaging (ISO 11607 Part 1 & 2, EN 868 Part
1, 2 & 5, ASTM D4728, ASTM F1886)
- Ageing Studies (ASTM F1980)
- Product Testing (ISO 15747, ISO 8536-4, ISO
22413, ISO 20696, ISO 20697)
- Usability Engineering (IEC 62366-1)
- Labelling (ISO 15223-1 & ISO 20417)
- Sterilization (ISO 11137-1, ISO 11138-2, ISO
11135, ISO 11737-1, ISO 17665-1)
- Medical Device Software (IEC 82304-1, IEC
62304, ISO/IEC 27002)
- Luer Connector (ISO 80369 Part 1, 7, 20)
- QMS (ISO 13485) & RMS (ISO 14971)
Software Skills
 Biomedical Signal & Image Processing -
MATLAB
 Circuit Simulation - Tina-TI & Multisim
 3D Modeling & Designs - Solid Works
 Basic C Programming - Dev C++
 Microcontroller Programming - Keil µVision
 Documentations - Microsoft Office
 Operating System – Windows
 PLM Tools – Windchill, Agile, MDRIM, TcU
Achievements
 Received Laptop as an award for securing
District 1st Rank in SSLC Examination (2010)
from Chief Minister of Tamilnadu Dr. M.
Karunanidhi.
 Selected as a “Scholar for GE Foundation
Scholar Leader Program in India 2014” and
won GE Foundation Scholarship (GE Foundation,
New York) of 4500 USD.
 Won “HCL ERS Knowledge Champion
Award” for 2 consecutive years (2021-22).
Personal Details & Hobbies
 Date of Birth: 21-Mar-1995
 Father’s Name: S. Thirunavukkarasu
 Nationality: Indian
 Languages: Tamil, English.
 Marital status: Single
 Hobbies: Reading books, Poem writing, Cooking
+91 9994501421 sathish.tiru@gmail.com
OBJECTIVE
QA & RA specialist and R&D Packaging Engineer with 4.8 years of experience in the
field and a strong track record of enhancing the efficiency of QA & RA processes and
Sustenance Engineering looking to apply skills in a position with a reputable firm.
EDUCATION
 M.E – Biomedical Engineering
College of Engineering, Guindy (CEG Campus), Anna University, Chennai.
14-Aug-2016 to 29-May-2018 9.2 CGPA – 2 nd Rank in the Department
 B.Tech – Biomedical Engineering
Vellore Institute of Technology (VIT) University, Vellore.
29-Jun-2012 to 31-May-2016 9.42 CGPA – 3rd Rank in the Department
 Higher Secondary Education
Government Higher Secondary School, Iyyangarkulam, Kanchipuram.
18-Jun-2010 to 7-Mar-2012 92.5% – District 1 st Rank among Govt., Schools
 Secondary School Leaving Certificate (SSLC)
Government High School, Collector’s Colony, Kanchipuram.
1-Jun-2009 to 7-Apr-2010 97.4% – District 1 st Rank
EXPERIENCE
 Professional I - Biomedical Engineer, Capgemini Technology Services India Limited
01-Nov-2022 to Till Date Talwade, Pune, Maharashtra - 412114, India
- R&D Sustenance Engineer, Boston Scientific India R&D Centre, Pune: Updating
packaging drawings, DV Protocols & Reports, ISO 11607 compliance matrix as per MDR.
- Epiphany to Baxter Migration: Preparing GSPR, Standard List, Checklists & TDR for
Epiphany Cardioserver Software as per EU-MDR & Baxter QMS Process.
 Senior Analyst – Regulatory Affairs
HCL Technologies Limited
16-Oct-2018 to 28-Oct-2022 Madurai - 625020, Tamilnadu, India
- J&J Depuy Synthes Spine: Prepared & reviewed (QA) the Checklists, SOPs, WIs &
Regulatory Submission Documents such as TDR, DoC, GSPR, IFU, RMR, Standard List
& Standard Assessments as per EU-MDR for Spine Implants & Surgical Instruments.
- Baxter SaMD Assessment: Derived the Regulatory Strategy & prepared the IEC 62304
Clauses Compliance Checklist for two newly developed SaMD Products of Class IIa.
- Baxter SotA: Primary QA & RA Reviewer and Approver for SotA standard assessments
and SME to develop the algorithm for automation of SotA standard assessments.
- Boston Scientific Urology Standard Assessment: Prepared the GSPR, Standard
Assessments & supported the Risk Management activities for Urology Products.
TRAININGS &
CERTIFICATIONS
 Hospital Training
1) LifeCare Hospital
23-May-2017 to 23-Jun-2017 - Kanchipuram, Tamilnadu.
2) Schieffelin Institute of Health - Research & Leprosy Centre
18-Sep-2013 to 19-Sep-2013 - Karigiri, Vellore, Tamilnadu.
 Industrial Internship Training
1) ALFA Surgicals
4-Dec-2014 to 3-Jan-2015 - Kuniamuthur, Coimbatore, Tamilnadu.
DECLARATION
I hereby declare that the information submitted all are true to the best of my knowledge.
Pune, Maharashtra.
08-July-2023 Sathishkumar Thirunavukkarasu
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