Summary
Overview
Work History
Education
Skills
Achievements And Awards
Disclaimer
Roles And Responsibilities
Instruments Used
Timeline
Generic
Vinothkumar Velappan

Vinothkumar Velappan

Bangalore

Summary

Seeking challenging opportunity in Design Verification and Validation (V&V) to utilize extensive industry experience and technical expertise for significant contributions to organizational success while advancing technical and leadership skills.

Overview

14
14
years of professional experience

Work History

Lead Engineer – Product Testing

Philips Medisize
Bangalore
12.2022 - Current
  • Led V&V deliverables for regulatory submissions in compliance with industry standards.
  • Developed and reviewed test methods, protocols/procedures for subsystem and system-level testing, including V&V, environmental, performance, reliability, and safety/regulatory tests.
  • Performed gap and impact analyses; established traceability matrices for NPD/CDMO projects.
  • Developed V&V strategies including test design, planning, reporting, and effort estimation.
  • Optimized test resources and Units Under Test (UUT) for improved efficiency.
  • Led and reviewed design and technical documentation to ensure quality and completeness.
  • Defined sample sizes, test methods, and validation strategies tailored to project needs.
  • Collaborated with external vendors to coordinate and review V&V deliverables.
  • Supported closure of regulatory and quality requirements to ensure compliance.
  • Applied risk management principles (FMEA, critical part ID, life/limits testing) in V&V activities.
  • Led lab qualification and productivity initiatives including fixture development, calibration, and IQ/OQ/PQ protocol execution.
  • Led V&V deliverables for regulatory submissions, including strategy, test planning, execution, and reporting.
  • Conducted gap/impact analyses, risk assessments, and established traceability for NPD/CDMO projects.
  • Collaborated with external vendors and test houses to define test scope and review deliverables.
  • Developed and reviewed protocols for verification, validation, environmental, reliability, and regulatory testing.
  • Ensured GMP and regulatory compliance, supporting audit readiness and documentation quality.
  • Initiated early testing with design teams to ensure testability, traceability, and early issue resolution.
  • Led root cause investigations and supported continuous improvement initiatives.

Lab Engineer I– Design Quality Assurance

BOSTON SCIENTIFIC
Gurgaon
06.2018 - 12.2022

Quality Control – Sr. Engineer

Kems Forging & Automotive PVT Ltd
Bangalore
09.2017 - 11.2018

Quality Control – Sr. Engineer

Gio Informatics Consultants Pvt Ltd
Bangalore
08.2015 - 08.2016

Calibration Lab – CMM Engineer

Accurate Engg. Co. Pvt. Ltd.
Bangalore
09.2014 - 08.2015

Quality – Line Inspector

SM INUSTRIES
COIMBATORE
08.2011 - 09.2014

Education

Bachelor of Technology -

BITS Pilani
01.2023

Diploma - Mechanical Engineering

Theni Kammavar Sangam Polytechnic College
01.2019

Skills

  • Test Method Validation (TMV)
  • Measurement System Analysis (MSA)
  • Verification and Validation (V&V)
  • Equipment Qualification
  • Product/Material/System Reliability Testing
  • Test Design Methodologies
  • GD&T
  • Gauge and Fixture Qualification
  • Manufacturing Process Insights
  • Good Documentation Practices (GDP)
  • Preventive Maintenance
  • Calibration Protocols
  • Internal & External Audits
  • ISO 13485
  • NCR/CAPA Management
  • Regulatory Knowledge
  • FDA 21 CFR Part 11
  • ISO 17025
  • MDSAP
  • IEC 60601 Series

Achievements And Awards

  • VMS Verification procedure developed and Globally Awarded best Preventive CAPA of the year.
  • Qualified 7 different Equipment’s in 6 months.
  • Two medical device testing laboratories setup with regulatory requirements, ensuring quality standards.

Disclaimer

I hereby declare that all the above information is true to best of my knowledge.

Roles And Responsibilities

  • Leading/Performing Test Method development and Test method validation.
  • Leading Design Verification and Test Method Validation for Medical Products.
  • Lab Equipment qualification through IQ, OQ, PQ process.
  • Leading Product Design Verification Testing.
  • Create Non-Conformance report for parts and process, Incident report, Deviation report process during testing & Lab management.
  • MSA study through Minitab (Gage R&R study, Bias & Linearity and kappa study).

Instruments Used

  • Vision Measurement System – OGP, Micro VU and Zeiss
  • Chambers (HALT, Altitude Chamber, Climatic Chamber)
  • Universal Testing Machine (UTM) (Make: Instron /Zwick/Mecmesin)
  • Axial Torsion Machine # TestXpert III (Make: Zwick)
  • Video Measuring System (VMS) (Make: Micro VU), and Measure Mind 3D (Make: QVI)
  • High-Pressure Leak Tester (HPLT) #Pressure Manager
  • Catheter Testing Equipment# (Make: MSI) & Tack Tester
  • Flow, Torque, Force, Thermal, Dimension measuring equipment / tools

Timeline

Lead Engineer – Product Testing

Philips Medisize
12.2022 - Current

Lab Engineer I– Design Quality Assurance

BOSTON SCIENTIFIC
06.2018 - 12.2022

Quality Control – Sr. Engineer

Kems Forging & Automotive PVT Ltd
09.2017 - 11.2018

Quality Control – Sr. Engineer

Gio Informatics Consultants Pvt Ltd
08.2015 - 08.2016

Calibration Lab – CMM Engineer

Accurate Engg. Co. Pvt. Ltd.
09.2014 - 08.2015

Quality – Line Inspector

SM INUSTRIES
08.2011 - 09.2014

Bachelor of Technology -

BITS Pilani

Diploma - Mechanical Engineering

Theni Kammavar Sangam Polytechnic College
Vinothkumar Velappan