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Career Objective
Seeking a full-time role with scope for effective utilization of Engineering design experience and
promoting further knowledge acquisition, thereby contributing to the growth of the organization and
myself.
Profile Summary
● Mechanical Engineer with 4+ years of professional experience in Medical device design.
● Experienced in Product development, Concept design and development, Design modification,
Drawing creation per ASME Y14.5M, Inspection Overlays, Tolerance stack up analysis.
● Strong Knowledge in NPD methodology, GD&T, Manufacturing processes, Risk analysis per
ISO 14971, Design control, EU MDR and FDA regulations related to medical devices.
● Experienced in Engineering Change management, BOM remediation in PLM tools.
● Experienced in Material qualification for ROHS3 and REACH compliance.
● Experienced in DHF remediation for medical devices.
● ASME GDTP- 1994 technologist certified. Certification No: GDTP T94-7954
● Proactive, Good Leadership Skills, Effective communicator, Result-oriented and Good team
player having cross cultural working experience.
Skill Set
Area Skills
Engineering NPD, GD&T, Concept generation, CAD modeling, Detailed Design, drawing
design creation, Design verification and validation, Tolerance stack analysis, Engineering
change management, DFMEA
Technical Siemens NX V8.5 with Team center, ADAPTIV, Solidworks, BCT Tools, SAP Tahiti,
competencies SWIM 10.1
Career Profile
Project Details Project Handles the EU MDR compliance activities of all Class I devices
Responsibilities ● Leading a Cross functional team of 8 Mechanical and Bio-Medical
engineers.
● Responsible for Training the team in Drawings and Material qualification
activities.
● Gap analysis of existing technical documentation for EU MDR.
● Drawing Gap analysis and material analysis from the drawings.
● Risk assessment of Class I devices using ISO 14971.
● Assessment of CMR substances in the materials used in the product and
benefit risk assessment.
● Creation of Test plan for requirement-based testing, Biological evaluation
report Per ISO-10993 and GSPR Checklist.
Employer HCL Technologies Ltd. (20th Aug 2018 – 19th Apr 2019)
Customer Leading Multinational Medical Devices company
Project Title ROHS3 compliance- Role Mechanical Engineer
Dispensing & Infusion
Period 20th Aug 2018 –till date Location Chennai, India
Project Details Project Handles the ROHS3 compliance activities of all BD’s Medical Management
System and Infusion product lines.
Responsibilities RoHS3 compliance
● BOM extraction of Dispensing parts and infusion parts from SAP Tahiti and
segregation of 20000+ Components as Make or purchased.
● BOM update based on addition or deletion of parts based on ROHS3
compliance.
Make:
● Analysis of material from drawing and qualification of material for ROHS3
Compliance using standard data sheet and material available.
● Self-declaration of Material conformance for Assembly and components
based on ROHS3 material risk.
● Revising Drawing update to reflect ROHS3 Compliance using Solidworks
with SWIM (TC).
● Revising drawing in SAP PLM, by means TC-SAP DIR workflow process.
Purchased:
● Preparation of the supplier data, supplier catalog number of purchased
parts for IPCA Tool) to obtain supplier response on ROHS3 Conformance
certificate.
● Risk assessment of “No information” components for Material risk,
Component risk and Supplier risk for ROHS3 material using ISO 14971.
● Recommending Testing of High-risk components if Material conformance
is not obtained.
● Self-declaration of low risk Assemblies based on ROHS compliance of sub
level components.
● Suggesting alternate components as ROHS3 compliance replacements with
cost benefit quotes.
● Creation of Material control number in SAP for addition and deletion of
parts to enable/prevent of purchases through procurement Team.
Employer TATA Consultancy Services Ltd. (25th May 2015 – 17th Aug 2018)
Customer Leading Multinational Medical Devices company
Project Title R&D Spine offshore Role Design Engineer
Personal details
Languages Known English, Tamil
Date of Birth 25th May, 1994
Marital Status Single
Nationality Indian
Sex Male
Hobbies Cooking, playing strategy games, reading books
Personal Strength
● Multinational Interaction in day to day Work
● Ability to work independently with limited supervision
● Proactive, Diligent work ethic, Strong interpersonal skills, Responsible and Positive attitude
● Customer focused, Positive and constructive approach to problem solving
Declaration
I hereby declare that the above furnished details are true to the best of my knowledge.