1. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
CAREER SUMMARY
Experienced professional in product design & development, risk management, regulatory compliance and project management. Extensive experience in class II & III medical devices including combination products, automobile and industrial products.
SKILLS / EXPERTISE
• Proven expertise in Systems Engineer, Design Engineer, Validation Engineer and Risk Engineer roles.
• Proficient in ISO 14971 Risk Management Procedure.
• Extensive experience in DFx, DFMEA, GD&T, Six sigma and VA / VE.
• Extensive experience in Electro-mechanical products design, plastic part design and machined parts design.
• Extensive experience in various phases of product design and development cycle from Concept generation, Prototype, Detailed design, Verification and Validation through Design Transfer.
• Extensive experience in 1D, 2D & 3D Tolerance analysis, and experience in tolerance analysis tools VisVSA and Sigmundworks.
• Extensive experience in CAD tools Pro/E, Solidworks and UG NX.
• Expertize in DOE, Measurement System Analysis, Process Validation (IQ, OQ, PQ).
• Experience in CAPA activities.
• Extensive experience in Requirement Management tool, IBM – Rational DOORS.
• Extensive in knowledge in Geometric Dimensioning and Tolerancing (ASME Y14.5-2009).
• Extensive experience in various International standards for medical devices and consumables includes, IEC 60601-1, IEC 60529, IEC 61025, IEC 60812, AAMI HE75, ISO 594, ISO 7864, ISO 7886, ISO 8536, ISO 1135, ISO 3826, ISO 10555, ISO 11040, ISO 15747, ISO 10993, ISO 15223, ASTM D4169, USP, European pharmacopoeia and FDA Quality system regulations 21CFR 820, 21CFR 210, 21CFR 4.
PROFESSIONAL EXPERIENCE
HCL Technologies Ltd, Chennai, India
Jun-2008 – Present
Leading IT & Engineering Service Company offering services includes medical devices, life sciences & healthcare, aerospace & defense, energy & utilities, automotive, financial services, industrial manufacturing, and consumer electronics.
Hospira Inc., Lake Forest, IL, USA
Jan-2013 – Present
Manufacturer of Infusion pumps, Consumables, Differentiated Drug Delivery products and Pharmaceuticals.
 Project: Modified Secure Lock for Gravity administration sets – (510(k) submission
Role: Systems Engineer
The scope of this project is to design and develop a new Secure lock adapter with alternate material to replace current Secure Lock and Option-lock distal adapters, which had complaints related difficult to establish secure connection which leads to leak. The current DHF documents for the administration sets are remediated during the course of the project to comply with 21 CFR part 820.30, 1 | P a g e

2. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
Design Controls & ISO 13485 Clause 7, Product Realization, and these documents are updated and provided as a supporting document for 510(k) submission.
• Performed as a Cross Functional Team Member and enabled regulatory team to submit the 510(k) on time.
• Developed System Architecture, Requirements management Plan, Design Inputs, and Trace Matrix.
• Co-ordinated with medical representative and developed Hazard Analysis, User Error Risk Analysis, Risk Management Plan & Report.
• Co-ordinated with medical team to develop Clinical Risk Benefit Analysis.
• Conducted design reviews with cross functional team.
• Co-ordinated with verification, validation and Human factors team to perform verification, validation and Human factor studies (Formative & Summative studies).
• Extensively used Rational DOORS to manage requirements and traceability.
 Project: Patient Controlled Analgesia (PCA) Consumables – 510(k) submission
Role: Systems Engineer
This is a design improvement project to address the risk of unintended bolus occurs during vial loading and manipulation. In addition to this change, the Secure lock adapters are redesigned with new material to replace current Secure Lock and Option-lock distal adapters. The current DHF documents for the administration sets are remediated during the course of the project to comply with 21 CFR part 820.30, Design Controls & ISO 13485 Clause 7, Product Realization, and these documents are updated and provided as a supporting document for 510(k) submission.
• Performed as a Cross Functional Team Member and enabled regulatory team to submit the 510(k) on time.
• Developed System Architecture, Requirements management Plan, Design Inputs, and Trace Matrix.
• Co-ordinated with medical representative and developed Hazard Analysis, User Error Risk Analysis, Risk Management Plan & Report.
• Co-ordinated with medical team to develop Clinical Risk Benefit Analysis.
• Conducted design reviews with cross functional team.
• Co-ordinated with verification, validation and Human factors team to perform verification, validation and Human factor studies (Formative & Summative studies).
• Extensively used Rational DOORS to manage requirements and traceability.
 Project: DHF Remediation for Consumables and Differentiated Drug Delivery products
Role: Design Engineer
The scope of this project is to remediate Design History files for Consumables and Differentiated Drug Delivery products (Combination products) which include Vials, Flexible containers, Add-vantage drug delivery system, and Prefilled syringes.
• Developed System Architecture, Design Inputs, DFMEA and Trace Matrix.
• Co-ordinated with medical representative and developed Hazard Analysis, User Error Risk Analysis, Risk Management Plan & Report. 2 | P a g e

3. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
• Co-ordinated with medical team to develop Clinical Risk Benefit Analysis.
• Extensively used Rational DOORS to manage requirements and traceability.
American Medical Systems, Minnetonka, MN, USA
Oct-2012 – Dec-2012
Manufacturer of Pelvic healthcare products to treat Enlarged Prostate, Erectile Dysfunction, Bladder leakage, Pelvic organ Prolapse.
 Project: Process Validation – Artificial Urinary Spincter
Role: Validation Engineer
The scope of the project is to validate (IQ, OQ, PQ) the injection molds and the Artificial Urinary Sphincter assembly line.
• Developed Validation plan, IQ, OQ, PQ protocols and reports.
• Developed Test method validation protocols and reports.
• Performed DOE, Gauge R&R and Process capability studies.
Baxter Inc., Round lake, IL, USA
Nov-2010 – Sep-2012
Manufacturer of Infusion pumps, IV solutions, Premixed drugs and drug-reconstitution systems, IV nutrition products, Inhalation anesthetics, and Pharmaceuticals.
 Project: Sustenance Engineering - Intravenous Therapy Nutrition Compounders
Role: Verification & Validation Engineer
The scope of the project is to design and qualify a part/vendor for various Intravenous Therapy compounder parts per medical design qualification process.
• Perform design changes.
• Prepare models and drawings with GD&T.
• Perform Tolerance Analysis using VisVSA / excel based tool.
• Developed verification and validation protocols and reports.
• Performed Fluid ingress test qualification per ISO 60529.
• Co-ordinate with Electrical team to conduct EMI-EMC verification.
• Conduct design review meetings.
• Coordinate with vendors/suppliers for prototype development and part qualification.
 Project: Non conformities and CAPA – Intravenous Therapy Nutrition Compounders
Role: Systems Engineer
The Scope of the project is to investigate the nonconforming and potential non-conforming events and performing corrective measures using six sigma methodologies.
• Performed as CAPA owner.
• Perform Complaint analysis and root cause investigation using various statistical tools.
• Perform engineering changes to address CAPA action item.
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4. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
• Developed verification and validation protocols and reports.
 Project: DHF Remediation – Access devices
Role: Systems and Risk Engineer
The scope of this project is to remediate Design History files for Access products line viz., transfer sets.
• Developed System Architecture, Design Inputs, and Trace Matrix.
• Co-ordinated with medical representative and developed Hazard Analysis, User Error Risk Analysis, Risk Management Plan & Report.
• Co-ordinated with medical team to develop Clinical Risk Benefit Analysis.
• Conduct design review meetings.
Ethicon Endo Surgery, Blue Ash, OH, USA (Working in offshore)
Jun-2008 – Sep-2010
Manufacturer of Various surgical equipment’s which includes Bariatric, Cardiovascular, Colorectal, Gynecologic, Plastic, Thoracic, and General surgery equipment’s.
 Project: Design of Transducer and Blade – Harmonic devices
Role: Design Engineer
The scope of the project is to design a transducer and blades for low frequency ultrasonic cutting and coagulating devices. The project involves concept generation, detailed design, Modal and FE analysis, Performing IEC 60601-1 compliance analysis like.
• Co-ordinate with FE Analysis team to create and analyze transducer and blade design.
• Design enclosure per IEC 60601-1.
• Perform design calculation for selecting shaft size, fasteners, plastic snaps etc.
• Prepare models and drawings with GD&T.
• Verify the design for manufacturability and ease of assembly.
• Perform Tolerance Analysis using VisVSA / excel based tool.
• Conduct design review meeting with client.
• Perform Value Engineering and Value Analysis.
 Project: Sustenance Engineering – Trocar
Role: Design Engineer
The scope of the project is to design a sealing mechanism to resolve the field issue, loss of insufflations during surgical procedure. The project involves concept generation, detailed design, FE analysis, engineering build support and conducting verification and validation study.
• Redesigned rib feature on the diaphragm to address insufflation loss.
• Verify the design for manufacturability and ease of assembly.
• Prepare models and drawings with GD&T.
• Perform Tolerance Analysis using VisVSA / excel based tool.
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5. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
• Co-ordinate with FE Analysis team to conduct engineering study.
• Conduct design review meeting with client.
• Perform Value Engineering and Value Analysis.
• Co-ordinate with onsite team to perform verification and validation study.
Pricol Ltd, Coimbatore, India
Jan-2007 – Jun-2008
Manufacturer and supplier of complete automotive products, automobile components, auto instruments and auto accessories.
 Project: New Product Development - Cabin Tilting Hydraulic Pump
Role: Senior Design Engineer
The scope of the project is to design and develop a Hydraulic pump and cylinder with safety operating valve to lift the cabin for Heavy commercial vehicles for Tata Motors, Eicher Motors, Ashok Leyland and Force Motors.
• Collect and understand product requirements from OEM.
• Responsible for Design and develop machined, forged and die casted components.
• Prepare FBD (Free Body Diagram) and Design calculation like pumping force determination, piston and cylinder design, spring design, and non-return valve design.
• Performed Cost estimation, Material selection, detailed design and drawing with GD&T, tolerance analysis, manufacturing feasibility study, and test fixture design.
• Performed product reliability analysis.
• Coordinate with vendors/suppliers for prototype development and production part qualification.
• Developed PPAP documents per ISO/TS 16949.
Premier Evolvics Ltd, Coimbatore, India
Dec-2003 – Jan-2007
Manufacturer of quality testing and on-line monitoring and services for the textile industry.
 Project: Design & Development of iQON A, X & AX Yarn Clearers
Role: Design Engineer
The scope of the project is to design and develop yarn clearer to detect color and mass variation present in the yarn for Savio Orion, Murata and Scholfharst.
• Developed plastic, die casted and machined components.
• Co-ordinate with Software team for interface development.
• Prepare models and drawings.
• Co-ordinate with vendors for Prototype development.
• Designed test fixtures to perform verification testing.
• Conduct field trials for performance verification of clearer.
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6. Karthikeyan Gopal
Grayslake, IL│+1 (847) 752-5694│gk.kaarthi@gmail.com│ www.linkedin.com/in/karthikeyangopal
Jaya Elektronic, Coimbatore, India
Jul-2002 – Nov-2003
Manufacturer of auto accessories.
 Project: New Product Development -Electrical horn
Role: Design Engineer
The scope of the project is to design and develop an Electrical Horns for two wheelers.
• Prepare strip layout for sheet metal components.
• Prepare models and drawings.
TOOLS / SOFTWARE
CAD Tools
: Pro/E, Solidworks, UG NX
Tolerance Analysis
: VisVSA, Sigmundworks
Requirement Management
: IBM Rational - DOORS
PLM
: SAP, Enovia, Teamcenter
CERTIFICATION
 Associate Value Specialist (AVS) – SAVE International
Certificate No. : 201011401
 Six Sigma Green Belt – HCL Technologies Ltd
 Solidworks Professional
 Preparing for GDTP Technologist certification
EDUCATION
 MBA-Operations Management
2008-2014
Indira Gandhi National Open University
Delhi
 B.E. - Production Engineering ( 80.28% - First class with Distinction)
1999-2002
Amrita Institute of Technology & Science
Coimbatore
 DIPLOMA - Automobile Engineering ( 86.81% - First class with Honors)
1996-1999
Nachimuthu Polytechnic
Pollachi
 SSLC ( 85% - School First)
1995-1996
Govt. High School
Pollachi
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