VIJAY KUMAR B

· Phone 7846817771
Vijayid2@gmail.com ·
Skype ID: vijay.840

OBJECTIVE
With 5+ Years of experience, to enhance my working capacities, professional skills, business Efficiencies
and to serve my organization in best possible way with sheer determination and commitment.

EXPERIENCE
2013 AUGUST – 2016 SEPTEMBER
V & V LEAD @ CALIBER ASSURANCE SERVICE
Worked with Medical Device Manufacturer to comply with below regulatory standards
ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-25, IEC 62304
to ECG Monitoring device, X Ray System and Multi Parameter Medical device

2016 OCTOBER – PRESENT WORKING

ASS CONSULTANT @ CAPGEMINI INDIA PVT. LTD
Working with Medical Device Manufacturer to perform Verification activities for Infant Incubator
and Fetal and Maternal Vital Monitoring device.

EDUCATION
MAY 2013
BACHELOR OF ENGINEERING, K.V.G.C.E, SULLIA
Marks Grade –62.88%
JUN 2009
DIPLOMA IN ELECTRONICS AND COMMUNICATION, V.V.E.T, MYSORE
Marks Grade –69.65%

SKILLS
 Performing Risk Management File and Developing Prcoess and Design
FMEA .
 Processe establishment as per IEC 62304,ISO 13485, ISO 14971
requirements
  Regulatory Testing according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8,
IEC 60601-1-11, IEC 60601-2-27, IEC 60601-2-49 , IEC 60601-2-46 ,IEC
60601-2-54.
 Preparing Project plan, Design and Development Plan,Risk Management
Report,Hazard analysis,Process and Design FMEA,Risk assement plan.
 Designing test plans and test protocols as per regulatory and design
requirements.
 Performing documentation and execution of verification and validation
plans, schedules, test plans, test protocols and reports.
 Experience in working with global and virtual team and working in
across cultural environment.

PROJECTS AND ACTIVITIES

1. Infant Incubator Verification.

Client : GE Healthcare,Bengaluru
Role :System Engineer
Team Size : 13+
Tools & Environment : HP Application Lifecycle Management(ALM), Agile Technique.
Duration: 1.5 Years

Activites Performed
1.Mapping regulatory standard such as IEC 60601-2-19 and IEC 60601-1-8 with respect to Product
2.Reviewieing System requirements and Software requirmeent during Product development.
3.Loading released software in to unit using Keil software
4.Executing System Test cases including Environemnt, Software and Mechanical test cases
5.Executing Sanity test case, Exploratory test cases, Finding and Logging defects in HP ALM tool.

2. Wearable ECG Monitoring device for CE certificate

Client: VIOS Medical, Bengaluru
Role: Verification and Regulatory Engineer
Team Size: 07
Tools & Environment: JIRA and Bitbucket tool,
Duration: 1 year

Actvities Performed :
 Compliance with IEC Applicable and standard.
(IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-1-8, IEC 60601-2-49)
 Preparing Test plan and executing test cases
 Black Box testing, Regression testing, Informal testing, and Formal testing.
 Failure Mode and Effects Analysis
 Risk Management Analysis

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  Test Simulation using WhaleTeq device for IEC 60601-2-27.
 Module testing, Unit testing. Boundary level testing, challenging Verification

3. C arm - X ray device Verification

Client :BPL Medical, Bengaluru

Role : Regulatory Engineer
Team Size : 05
Duration: 1 Year
Actvities Performed
 Preparing Risk Management reports as per ISO 14971
 Implementing ISO 13485 process

Involving in Pre-compliance and compliance Test IEC 60601-1-2, 4th Edition

Preparing Service and User Manual
 Preparing Technical Construction File (TCF)
 IEC Standards Mapping.
 Mapping with MDD rules.
 Preparing SOP
 Executing System test cases
 Preparing and executing unit level test cases

COMPUTER SKILLS :
 Familiar with HP ALM tool, Keil tool,
 Familiar with OrCad capture CIS Elite v16.6.0
 Familiar with WhaleTeq Application for ECG device testing
 Familiar with JIRA and Bitbucket tool
 Familiar with digilent waveform tool
 Strong control on MS office.

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AWARDS AND RECOGNITION

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PERSONAL PROFILE

Full Name Vijay Kumar.B

Father Name Basavaraju
D.O.B 23 April 1989
Gender Male
Nationality Indian
Permanent Address #604, 3rd stage,
R.S Naidu Nagar
Mysore-570007

Present Address #167, Groundfloor

Shivalingayya colony
Murugesh palya
Bengaluru-560017
Maritial Status Single
Languages Known English, Hindi, Kannada

I here by state that the above mentioned all details are true & belief to my knowledge.

Place: Bengaluru Vijay Kumar. B