Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Dossier
Languages
Timeline
Generic

RAJIV SHARMA

Newark,USA

Summary

Total experience of more than 20 years in mechanical engineering. 10+ years of exp. in new product design & development (NPD) for Mechanical & Electro-Mechanical devices. 5 years of exp. in Manufacturing process/machines development/improvement. 5 years of exp. in sustaining engineering activities. 3 years of experience in the Home Appliance industry. 10+ years of exp. in the Medical Industry (USA only). 7.5+ years of exp. in the Automobile Industry (India + USA). 6 yrs. of hands-on experience with design calculations for electromechanical machines or robotics machines. 10+ years of experience in Tolerance stack up (Worst case & RSS). 10+ years of experience in ASME Y14.5 GD&T application. Familiar with 6-sigma methods (DMAIC & DMADV). 10+ years of experience in CAD tool Pro-E Wildfire (Creo). 5+ years of experience in CAD tool like UG NX 2007 5+ years of experience in Solid Works 2017 - 2021 Rich experience in PLM tool like Windchill and Teamcenter. Right attitude/approach towards Root cause analysis and problem-solving skills, along with excellent communication skills. Skilled in liaising and communication with suppliers/vendors, technical partners/ collaborators, and cross-functional team in an organization for timely development of products/parts for more than 10 years. Good understanding of 21 CFR 820, cGMP practices and ISO 13485. Good understanding of FDA and MDR regulations in the Medical Industry. Well familiar with EMC/EMI standards, UL certification, and IP6X rating. 10+ years of experience of design and development with sheet metal shields & enclosures/housings for the packaging of electrical components like hard PCB boards and flexible PCBs. Worked in structural & thermal analysis of PCBs enclosures. Short term experience of 6 months with Ansys. 11 years of experience with Sheet metal, machined, die casting & plastic parts design & development. 8+ years of experience with Prototyping and testing. 6+ years of experience in Jigs and Fixture design. Deft in managing entire spectrum of Product Development activities, which includes feasibility study, design concept generation and selection, Prototype development/validation, Design Optimization, Design Verification/Validation testing and production release. Very good understanding of DFM and DFA. Well familiar with “Value creation/addition” (cost reduction) activities. Excellent communication and interpersonal skills. 10 years of exp. with project management. Handled a team of 5-8 onsite/offshore engineers while working with Siemens Healthineers and 3-5 onsite/offshore engineers with Larsen & Toubro technology services.

Overview

26
26
years of professional experience

Work History

Senior Mechanical Engineer

FILAMATIC
Baltimore, MD, USA
12.2024 - 04.2026
  • Worked as a Senior mechanical engineer and responsible for designing & developing Liquid filling systems for medical industry per 21 CFR 820 and ISO 13485.
  • These systems are capable of filling, capping and labelling the containers.
  • Responsible from start to production for multiple projects.
  • Integrating labelling machines with liquid filling machines.
  • Designing & developing after-sales tooling requirements.
  • Creating 3D models & 2D drawings using CAD tool SolidWorks and Vault.
  • Conducting design reviews with customers to collect feedback from time to time.

Mechanical Engineer

Pentangle tech services
Farmington Hills, MI, USA
08.2024 - 12.2024
  • Worked as a Mechanical Engineer and was responsible for understanding design issues, evaluating the impact of design changes on other product lines
  • Communicating with cross-functional teams (Internal & External) to collect data and input from a failure/issues standpoint.
  • Preparing a troubleshooting report for review with the customer for feedback/approval.
  • Conducting design modification reviews and seeking approval from the Customer.
  • Client: Schwartz Industries (Automobile) - Allabama, USA

Senior Mechanical Engineer

Terumo cardiovascular systems
Elkton, MD, USA
09.2022 - 06.2024
  • I have worked as a Senior Mechanical Engineer and was responsible for planning and implementing projects to develop, install, and qualify new machines using methods of IQ, OQ, and PQ, and/or new processes for manufacturing new products or for improving existing machines and/or processes according to business plan objectives.
  • Making sure medical devices are compliant as per FDA and MDR guidelines.
  • Worked in Medical device directive (MDD) project to a certain extent.
  • Provide engineering input in the design, fabrication, development, installation, validation, and qualification of equipment/processes.
  • Provide engineering input for feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment.
  • Lead cause-identification and problem-resolution using DEMING cycle for various types of production related issues.
  • Partnered closely with manufacturing, Engineering and supply chain
  • Monitor and control programs, identify issues and ensure they are resolved.
  • Ensure proper documentation is prepared or corrected to reflect any changes implemented.
  • Assist in the completion of engineering tasks or projects for lower-level engineers.
  • Used SolidWorks to create 3D CAD models and 2D drawings for new and existing machines.
  • Role & Responsibilities:

Mechanical Engineer

HCL America Inc.
CA, USA
05.2017 - 09.2022
  • Worked as a Mechanical Engineer in R&D team in the Role of “Work package Owner” (WPO Role) and responsible for complete design life cycle using Stepper motor driven mechanisms (Rack & Pinion mechanism & Belt driven mechanism) for diagnostic machines.
  • Designed & developed Plastic parts like safety guards, cuvette segments for Dilution Ring, Small housings for electrical parts for diagnostic machines.
  • Also contributed to design & development of Structures & Covers.
  • Participated in FEA static structural analysis for chassis structure for diagnostic machines.
  • Responsible to design/develop plastic, sheet metal, Pressure die casting and machined parts.
  • Responsible for creating, modifying & releasing 2D drawings & 3D models using UG-NX & GD&T.
  • Responsible for creating & releasing 2D drawings for all kinds of Jigs & Fixtures for a particular sub-system using UG-NX & GD&T.
  • Responsible for addressing & solving manufacturing issues at the vendor end with the co-ordination of manufacturing engineer.
  • Responsible for all kinds of related design calculations and Tolerance stack up, Modified RSS.
  • Responsible to conduct and achieve design approval from design review standpoint.
  • Responsible for developing engineering prototypes and validating against requirements.
  • Responsible for supporting Design verification/validation activities.
  • Responsible for developing Functional Specification documents.
  • Responsible for supporting Characterization testing.
  • Client: Siemens Healthineers (Laboratory Diagnostics) - Glasgow, DE, USA
  • Role & Responsibilities:

Mechanical Design Engineer

Larsen & Toubro Technology Services
USA
08.2011 - 05.2017
  • 2.5 years of employment in India (From Aug2011 until Feb 2014), at location Gujarat (India).
  • 3 years 2months of employment in USA (From March 2014 until May 2017), worked for multiple clients.
  • Total more than 5.5 years of employment.
  • Worked for the first client “Polaris Industries” at Wyoming, MN in the domain of Motorcycles as Mechanical Design Engineer.
  • Worked for the second client “Hill-Rom” at Batesville, IN in the domain of Maternity Beds as Mechanical Design Engineer.
  • Worked for the third client “Medtronic” at North Haven, CT in the domain of surgical devices as Mechanical Design Engineer.
  • Highlights in Polaris Industries (Client Aug2011 - Feb2015):
  • Design & Development of automobile sub-systems like Front Fairing, Driver controls, Driver & Passenger seat assembly, driver and passenger footrest, Handlebar assembly, Rear & front wheel covers & rear light assembly.
  • Participated in Design Review for sake of DFM and DFA feasibility.
  • Highlights in Hill-Rom (Client March2015 - Nov2015):
  • Worked on maternity bed subsystems like Air systems, Head deck lift system, Footrest systems for value engineering project in Sustaining Department using CAD software SolidWorks.
  • Converted metal Air housing into plastic air housing and introduced savings of approx. 70K – 80K achieved in Air Systems.
  • Highlights in Medtronic (Client Dec2015 - May2017):
  • Worked on Surgical devices Like ENDO STITCH 10mm using CAD software CreO.
  • Worked on ergonomic plastic Handle design & development.
  • Fixed design issues in gripper design using Tolerance stack-up analysis (Worst case).

Design Engineer

iGATE Patni
Hyderabad, India
01.2011 - 08.2011
  • I worked as a Design Engineer.
  • Designing 3D concepts in the area of plastic and sheet-metal parts.
  • Responsible for managing 3D & 2D data in Windchill database.
  • Review and check all deliveries before final delivery to the client.
  • Role & Responsibilities:

Design Engineer

Dell Engineering services
Hyderabad, India
05.2010 - 01.2011
  • I worked as a Design Engineer.
  • Designing 3D concepts of casting and sheet-metal parts.
  • Responsible for managing 3D & 2D data in Teamcenter database.
  • Review and check all deliveries before final delivery to the client.
  • Role & Responsibilities:

Design Engineer

Tech Mahindra (Satyam)
Hyderabad, India
08.2007 - 05.2010
  • I worked as a Design Engineer.
  • Lead the projects from concept to production by developing mechanical systems of dishwasher structural components and assemblies such as tub structure, aesthetic features including doors and user interfaces such as consoles.
  • Performed variation analysis for product performance and design validation, initiating the teardown and cost analysis of the products.
  • Worked with global team members to ensure that design meets the requirements and confirm robust product design methodology.
  • Performed tolerance stack up analysis for Functional and Craftsmanship requirements.
  • Used GD&T to define 2D drawings effectively.
  • Role & Responsibilities:

Development Engineer

Unilink India Ltd.
Noida, India
04.2006 - 08.2007
  • Worked as Development Engineer.
  • Was responsible for New Product Development (NPD) from beginning till approval of production of components.
  • Worked on various projects related to component design & development, complex part modeling (Pro-E 2.0), sheet metal, surface modeling, disassembly modeling and drawing generation.
  • Developed fixture for machined components.
  • Carried out PPAP process for machining components, starting from beginning to the launch of production.
  • Role & Responsibilities:

Manufacturing Engineer

Escorts Ltd.
Faridabad, India
07.2000 - 06.2002
  • Worked as Manufacturing Engineer.
  • Creating 2D drawing for Jigs and Fixtures in AutoCAD.
  • Supervision of manufacturing shop floor for smooth flow of production process as per 5S methodology.
  • Highlights:
  • On the manufacturing shop floor, I dealt with the machining department (centerless grinding) for 14 months.
  • On the manufacturing shop floor, I dealt with the assembly department for 10 months.

Education

B.E. - Mechanical Engineering

Nemi Chand College of Engineering
Panipat, Haryana, India
01-2005

Skills

  • CAD Software’s: Pro-E (Creo 30)/Windchill PDM link, UG-NX/Team Center and MS Office & Solid Works 2017-2021/vault
  • Engineering calculations
  • Manufacturing processes
  • Computer-aided design
  • Prototyping
  • Structural analysis
  • Failure analysis
  • Stress analysis
  • Engineering standards
  • Machine design
  • Design optimization
  • Design for manufacturing
  • Engineering drawings
  • Metal fabrication
  • Microsoft Excel
  • SolidWorks 3D models
  • Risk assessment
  • Staff management
  • Mentoring and training
  • Mechanical system design
  • Continuous improvement
  • CAD drafting
  • Project management
  • Troubleshooting
  • Data analysis
  • Manufacturing process controls
  • Risk management
  • Load calculation
  • Highly skilled in 3D and 2D CAD
  • Root-cause analysis
  • Injection molding
  • Data interpretation
  • Complex problem solver
  • Technical documentation
  • Statistical analysis
  • SAP
  • Component functions and testing requirements
  • Design reviews
  • Regulatory compliance
  • Test procedures
  • Product development
  • Lean principles
  • Six sigma methodologies
  • Prototype development
  • FMEA

Accomplishments

  • Creative Problem Solving: - Resolved product issue through consumer testing.
  • Design - Responsible for creative design for prominent HYDRA.
  • Process Improvement - Created new departmental procedures manual. Assessed organizational training needs.
  • Documented and resolved [Issue] which led to [Results].
  • Resolved product issue through consumer testing.
  • Achieved [Result] by completing [Task] with accuracy and efficiency.

Personal Dossier

  • Present Address: 2025 Rivers Dr. Newark, DE - 19702
  • Visa Status: I-140 Approved – Green Card in progress

Languages

Hindi
Full Professional
English
Full Professional

Timeline

Senior Mechanical Engineer

FILAMATIC
12.2024 - 04.2026

Mechanical Engineer

Pentangle tech services
08.2024 - 12.2024

Senior Mechanical Engineer

Terumo cardiovascular systems
09.2022 - 06.2024

Mechanical Engineer

HCL America Inc.
05.2017 - 09.2022

Mechanical Design Engineer

Larsen & Toubro Technology Services
08.2011 - 05.2017

Design Engineer

iGATE Patni
01.2011 - 08.2011

Design Engineer

Dell Engineering services
05.2010 - 01.2011

Design Engineer

Tech Mahindra (Satyam)
08.2007 - 05.2010

Development Engineer

Unilink India Ltd.
04.2006 - 08.2007

Manufacturing Engineer

Escorts Ltd.
07.2000 - 06.2002

B.E. - Mechanical Engineering

Nemi Chand College of Engineering