Medical Device Design Engineer
Resume:
Contacts
Mobile:
Email:
**************@*****.**
m
Present location : Madurai,
Tamilnadu
Permanent Address
South Alagapuram, salem,
Tamilnadu, Tamilnadu
636004
Personal Data
Name : Mohanvikas M
Age : 26
Sex : Male
Marital Status : Single
Blood Group : A1+ve
Date of Birth:19 May 1994
Languages Known: English,
and Tamil
Hobbies : Reading, Dancing,
Travelling, Playing Cricket
MOHANVIKAS M
B.E IN MECHANICAL ENGINEERING
Objective
Looking for a challenging opportunity to work for an organization to enhance my knowledge and skill and be a part of organization goal and work in team to achieve the objectives
Profile Summary
4.5 years of Industrial experience in Medical device industry
Strong industrial knowledge in medical devices design and development process and quality management system per ISO 13485, 21CFR Part 820.
Good knowledge in MDD and MDR regulations and FDA Regulation and the key changes between MDD and MDR.
Expertise in complaint handling as per regulatory requirement.
Expertise in submission of Medical device reports to FDA through Trackwise tool.
Good knowledge in reliability testing and reliability analysis.
Familiar with gap assessment and remediation as per MDR.
Good knowledge about dialyser filters and PSD veritas
Expertise in DHF and DMR document structuring in Teamcenter unified
Technical Skills
Complaint Handling
EU MDR Regulations
21CFR Part 820
Reliability Testing
Test Method validation
Equipment validation (IQ,OQ,PQ)
Sterility Assurance
Animal Origin
FMEA
MDR Gap Analysis
CC & PQA
Professional Experience
Design Engineer at HCL Technologies Ltd, Madurai R&D section From February 2016 to Present
Project: Complaint Handling
Client: Baxter Healthcare Ltd
Responsibilities
Analyse the complaints from Baxter and check an investigation is required.
Track and update the complaints in Trackwise tool.
Analyse the reportability of the complaint and submit electronic Medical device report (eMDR) to FDA as per 21 CFR 803
Do the proper investigation of the complaint to obtain the root cause.
Investigation includes Sample evaluation, Design History review, Manufacturing review, FMEA review etc.
Support regulatory submission to US, EU and other vigilance reports
Project: Reliability Testing & Modelling on NPD (US) Client: Baxter Healthcare Ltd
Responsibilities
Reliability Testing & Modeling, Ageing Life cycle & reliability analysis, Mean time Between Failures, Calibration, Validation in New Prototype Product.
Responsible for design validation and verification for medical device and Test method execution and Test Method validation.
Play role on CC (Configuration Controller) and Familiar with Quality system requirements, ISO 13485, Quality auditing.
To gather technical information from SMEs and On-Site engineering team on product changes and documentation updates. Project: TcU migration for Medolla (Italy), Meyzieu (France), Ahmedabad (India)
Client: Baxter Healthcare Ltd
Responsibilities
Worked for Dialyzers, Dialyzer Filters and Pharmaceuticals.
Collecting and analyse inputs from client.
Plan and organise the team activities and Analysing and managing project risk.
Preparation of Parts document, Dataset, DMR Structure and BOM structure Templates.
DHF structuring and DHF classification
Study and understanding of DMR and DHF documents like Design and Development plan, Design input and output documents, Design Control documents, Verification and validation documents, Design review documents Clinical Evaluation Documents, Biocompatibility Evaluation documents, Risk Management Documents, Declarations of Conformity documents, Technical Documents etc.
Support Project Manager for delivering the output on time.
Served as PQA and CC for the project.
Find the root cause by quality tools like 5why analysis, Fishbone diagram, FMEA etc
Project: MDR Remediation
Client: Baxter Healthcare Ltd
Responsibilities
Involved in EU MDR Gap Analysis, Biocompatibility Gap Assessment, and sterilization Assurance Gap Assessment, Animal Origin Gap Assessment.
Well-versed in the methodologies of EU MDR regulations, Biocompatibility and sterilization processes, Animal Origin Processes for Advance Surgery Products.
Academic Profile
Qualification Institution University/Board Year Percentage B-E
(Mechanical
engineering)
AVS Engineering
college, salem
Anna university 2015 75.7 (CGPA)
Diploma in
Production
Engineering
Thiyagarajar
Polytechnic
collge,salem
State Board of
Technical
education
2012 87.3
SSLC Little flower
Higher Secondary
School, salem
State Board 2009 79.4
Design Software
Auto CAD
Solid works
PLM Tool
Team Center (TcU) – PLM software
Trackwise
Declaration:
I hereby declare that all the information mentioned above is true and complete to the best of my knowledge.
Date: 31/05/2020
Place: Salem, Tamilnadu
Performed regulation activities as per ISO 13485, ISO 14971 and 21CFR PART820.
Junior CAD Engineer at ASE Structure Design Pvt Ltd From Jan 2016 to October 2016
Responsibilities
Prepare an Initial drawing based on preliminary inputs from the customer for trails and customer approval.
Prepare site drawing as per Australian standards and maintain database of Designed files.
BOM creation activity, Validation and verification for Component Drawing
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