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