MEDICAL DEVICE DESIGN/QUALITY ENGINEER

Siva S
Contact : + 91 6369930665
E-Mail Id : [email protected]

CAREER PROFILE
A Reliable, Dedicated and Highly Skilled Professional with 7 years of experience as a Design Engineer in Medical
Domain and Mechanical Domain. Expertise in DHF remediation projects, Development of Therapeutic/Diagnostic
Catheters, Design Control activities, Quality Assurance, Regulatory Compliance with EU MDR/FDA, and Project
Management. A consistent team player with leadership skills, project quality analyst skills and strong interpersonal
skills. Good Knowledge in ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 803.

WORK EXPERIENCE
7 Years of Experience in the Relevant field of Medical Devices as well as Manufacturing Domain.

SOFTWARE SKILLS
AutoCAD, Solid Works, Creo, NX, M.S Office, PM Smart.

PLM SKILLS

• Adaptive : Hands on Experience in Datamining and Route/Promote activities

• Windchill : Hands on Experience in Datamining, Check In/Out, CR/CN activities
• Agile : Hands on Experience in Datamining, Change Management, Approval activities
• ETQ : Hands on Experience in Datamining, Change Management, Approval activities
• Tungsten : Basic knowledge in Datamining

WORK PROFILE
• Company : HCL TECHNOLOGIES
Designation : Technical Lead
Work span : From March 2019 to Present date.

• Company : HUSKY Injection Molding

Designation : Production Designer
Work span : From October 2016 to February 2019.

• Company : JOTHI MALLEABLES PVT LTD

Designation : Trainee Design engineer – New Product Development
Work span : From January 2016 to October 2016.

Projects Handled in HCL:

Project 1:
Client: Biosense Webster Inc. Platform: Medical Project Name: JNJ Surgery

• Responsible for Detailed Design, Mfg. Drawing release.

• Understand the voice of customer, create Product Requirements which are top-level design inputs.
• Prepare Design Trace Matrix where the Products requirements are converted to Design Input elements.
• Solid experience in Concept & detailed development, Creation of complex 2D/3D Models & Drawings for
Medical tools.
• Participate in design reviews to evaluate designs and to assist identify and finalize.
• Responsible for risk management activities including planning, perform product risk assessment, facilitate the
failure mode effective analysis and overall risk summary reporting per ISO14971.
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• Responsible for Risk Mitigation activities thru Clinical Evaluation & Post Market Surveillance feedback.
• Perform remediation of DHF documents for catheter & other medical devices
• Perform the Product Complaint Analysis & update the Risk management report based on the product
complaints
• Ensure compliance of projects to FDA QSR 21 CFR Part 820 and ISO13485.
• Create Medical Device Reporting Forms & reports to US FDA for Regulatory requirements.

Project 2:
Client: Depuy Platform: Medical Project Name: PVE

• Lead a team for Process Verification and Validation compliance for Joints on Depuy Part codes for EU MDR
based on ISO13485
• Verification & Validation of documents like OQ, PQ, IQ, Measurement system analysis, Process Flow, PFMEA,
Control Plans, Manufacturing Materials and Supplier Validation Documents.
• Review and Submission of the Finished Documents for Delivery and Approval.
• Assessing gaps in Design and Manufacturing areas for the medical instruments/implants in Process flow,
PFMEA, Control Plan, Manufacturing Materials and Supplier Validation documents.
• Checking the drawings are up to date as per latest revisions and manufacturing process for the latest drawing

Project 3:
Client: Synthes Platform: Medical Project Name: MPI

• Manufacturing Process Information compliance for Class 1 Synthes Medical Devices for EU MDR.
• Data collection of Part Drawings, Process Risk Management, Design Evaluation File, Approved Supplier List,
Process Router, Special Process validation documents.
• Execute and Review the MPI Template reference to SEP-188
• Upload and Promote the MPI Document in Windchill/Agile PLM for EUMDR compliance.
• ASL preparation for External medical device suppliers.
• Client interaction for Project co-ordination
• Lead a team in DHF remediation project for Creating MPI for manufacturing medical instruments/Implants as
per EU MDR regulations based on ISO-13485.

Project 4:
Client: Depuy Platform: Medical Project Name: MIC

• Checking and conforming the compliance of EU MDR for inspection checklist.

• Data Collection of part drawings and receiving inspection checklist .
• Updating the labeling inspection checklist for variant part codes.
• Updating the 2D AIDC Checklist .
• Updating dimension based on CTQ.
• Review and release the MIC Document.
• Responsible for Change request.

ADDITIONAL DUTIES AND RESPONSIBILITIES:

HCL Technologies Ltd

• Managing a team of engineering resources with quality and on time delivery

• Acting as a bridge between client and executors to update, perform a task efficiently.
• Planning, execution and closing of audits and conducting internal/external audits as per QMS to ensure
regulatory compliance.
• Experienced in Change control activities as per QMS and Supplier agreements.
• Proficient in preparing CAPA and NC resolving techniques.
• Performed Root cause analysis to identify quality issues.
 MEDICAL DEVICE DESIGN/QUALITY ENGINEER

• Preparation of trackers for follow-ups and team utilization perfectly as per project requirements.
• Organizing the delivery, coordinating the team issues, and solving through quick meetings.
• Experienced in creating Change request, change notice, Change order activities.
• Trained and Experienced in QMS audits and Delivery quality audits
• Front End and Represented the team in Senior Management Review (SMR) meeting.
• Performed a role of PQA (Project Quality Analyst) for the project
• Experienced in creating DAR, maintaining quality records such as QA workbook, Review record, Checklist.

Husky Injection Molding

• Design of hot runner systems for Medical, Automobile, Beverages & Non-Beverages, Closure, and other
markets.
• Finite Element Analysis.
• Component Study & Feasibility Study.
• Finalizing the drops requirements.
• Confirming melt channel size, melt channel layout and deciding manifold profile for hot runners.
• Considering the Tolerance and functional dimension while designing the Tools.
• Selection of suitable material for tools & hot runner components with respect to customer resin.
• Selection of suitable nozzle tips by considering the customer inputs and finalizing the hot runner parameters
for design
• Making 2D-Detailing & BOM for the Respective components.
• Preparation of bill of materials.
• Releasing 3D & 2D Drawing to Manufacturing and Project Engineer for Approval
• Attending trails and analyzes the problems.

Jothi Malleable PVT LTD

• 2D to 3D model conversion using Unigraphics (NX 7.5, NX-Ideas, Auto CAD)

• Gating, Runner Riser Design ,core and cavity extraction
• Modify the part or drawing as per the customer requires
• Creating models for 3D PRINTING
• Setting up the printing machine and creating the tool path
• Customizing customer IGES,STEP formats using solid works
• Creating 2D layout for gating system
• Updating the model for simulation

KEY SKILLS
• Good management skills to co-ordinate a team of resources with proper follow up.
• Hands on experience in GD&T per ASME Y14.5, Tolerance Stack up analysis, & Design Control documentation.
• Preparation of CAPA, DAR, Review record, Checklist, Estimations.
• Being Highly Skilled in Conceptual Design and drafting.
• Comprehensive understanding of engineering and design principles also ability to take responsibility and full
dedication in assigned work.

ACHEIVEMENTS
• Rewarded for Value Creation in the Project by cost saving up to $439
• Got Appreciation from Reporting Manager for Team managing and on time delivery.

CERTIFICATION
• ISO 13485:2016 Medical Device Quality Management System Internal Auditor from TUV.
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STRENGTH
• Quick learning, Confident, Self-motivated, Adaptability.

OTHER DETAILS
• Father’s Name : Subramanian G
• Date of Birth : 17 February 1991
• Total Years of experience : 7 years
• Marital Status : Married
• Languages Known : English/Tamil
• Expectation : Better career prospects, professional growth, and opportunities

DECLARATION
I hereby declare that the above-mentioned information is true to the best of my knowledge and belief.

Place: Madurai. (Siva S)