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Mechanical Design Engineer Resume

Shelton, CT


  • Project management certified professional with over 5 years of experience in Product Design & Development/ R&D/ Mechanical Engineering with hands-on experience and extensive knowledge in designing the parts from concept to production applying the experience in designing plastic injection molded and metal components in the regulated medical device industry.
  • Proficient in working on CAD/CAM tools majorly Pro/E, SolidWorks, UG, AutoCAD/Inventor, tolerance stack-up and GD&T analysis, cGMPs, CAPA, Gage design, DFA/DFM, DOE, Design/Process FMEA and RCA.
  • Hands on experience with FEA and static/dynamic simulations in ANSYS, ABAQUS, MATLAB, Simulink and Graphical User Interface (GUI).
  • Thorough knowledge of Design Controls, FDA’s QSR and ISO regulations and GLP guidelines specially 21 CFR 820, ISO 13485, ISO 11608, IEC 60601 and 510(k) requirements and review process.
  • Proven track record of consistently demonstrating the ability to handle multiple task demands with competence & integrity to high quality standards, while also meeting the deadlines.
  • Developed solutions to design problems through the application of engineering principles, analysis, and empirical methods.
  • Highly skilled and motivated team individual with excellent organization, communication, technical problem solving skills and great inter-personal skills.


Confidential Shelton, CT
Spine Products
Mechanical Design Engineer (Contractor)

  • Generated concepts and mechanical designs for spine implants and surgical instrumentation.
  • Created 3D models and manufacturing drawings per best engineering design practices.
  • Performed engineering analysis - including tolerance stacks, FEA structural analysis and FMEA.
  • Interfaced with vendors for prototyping, manufacturing, standard instruments and testing.
  • Interfaced with surgeons, industrial designers and marketing personnel to create designs.
  • Assisted in the development of verification and validation protocols, tests and reports.
  • Document data and procedures per Quality System.

Confidential York, PA
Drug-Delivery Devices
Design Engineer (Contractor)

  • Worked as a part of a small, dedicated, cross-functional product development team.
  • Liaised and worked with the customer and marketing team to identify customer needs.
  • Translated customer requirements into product requirements and compiled the Design Input Document.
  • Performed various CAD iterations and fabricated prototypes in conjunction with the internal prototype shop and outside suppliers.
  • Performed engineering analysis (FEA, moldflow, GD&T, 1st principles) of designsin accordance with ASME
  • Y14.5 principles.
  • Developed and executed test protocols and documented the results.
  • Collaborated with the pharmaceutical scientist to ensure drug/device compatibility.
  • Collaborated with the manufacturing engineer to ensure design manufacturability and successful design
  • transfer.
  • Identified and evaluated vendors to support product development.

ConfidentialMahwah, NJ
Surgical Implants and Instruments
Product Design Engineer (Contractor)

  • Worked with Windchill Enterprise Content Management System (ECM), Supplier Production Part Approval Process (SPPAP) and converting Unigraphics Models into Pro/E models.
  • Responsible for the timely and accurate creation and verification of 3D solid models utilizing GD&T, Tolerance Stacking for clearance/interference studies, FEA analysis and other customer specific deliverable requirements.
  • Generated concepts/ideas using Pro/E, SolidWorks that revolve around equipment/fixture type solutions.
  • Worked closely with the in-house Engineering Workshop in getting equipment/fixtures fabricated, or identify suitable external engineering fabrication shop where appropriate.
  • Developed and implemented appropriate supporting documentation which complies with cGMP in conjunction with other team members.
  • Served as mentor to Designers and Associate Designers, when required.

Confidential.Franklin Lakes, NJ
Drug-Delivery Devices
Research and Development (Consultant)

  • Performed a wide range of engineering work required to support qualification of alternate resin materials in disposable syringe and needle products.
  • Responsible for Plastic mold designs of BD Pen II and Pen II B.
  • Assisted in prototyping designs and assembling customer samples, design simple fixtures, develop sensible batch assembly and test procedures.
  • Developed test methods and designing fixtures as appropriate, as well as validating test methods by conducting Measurement Systems Analysis (MSA) and INSTRON type testing.
  • Designed various testing and inspection fixtures and gauges for Physiojet and Pen II B assemblies.
  • Assisted in maintaining the complete design control process including report making and maintaining logs, files such as Design History Files and Design History Records.
  • Performed preventive maintenance on equipment to support scientific and technical objectives as well as meet regulatory and governance requirements maintaining Good Laboratory Practices (GLP).
  • Conducted detailed design reviews, Gauge R&R and capability studies.

ConfidentialNewark, NJ
Non-Toxic Biomaterials
Research Assistant

  • ­Conducted research and examined production of nanometer-diameter polymer fibers (majorly from SOY and PAN with water as the solvent), giving particular attention to the key features like jet-initiation, fiber architecture and fiber distribution by using electrospinning technique for tissue engineering, biomedical, drug-delivery, medical device coating and antibacterial applications.
  • Prepared the ICP, AAS and WET analysis.
  • Planned and designed coaxial and triaxial electrospinning set-up.
  • Scanned electron micrographs showed the resulting electrospun soy fibers possessed smooth morphology with diameters ranging from 200 nm to 2 μm.
  • Trained and supervised undergraduate students, graduate students, and high school teachers.
  • Monitored the research group’s lab including keeping it organized and maintaining equipments.

ConfidentialDelhi, India
Diagnostic Devices
Biomedical Engineer

  • ­Designed and developed X-Ray machines and associated production tools and fixtures for assembly, testing and inspection using CAD/CAM tools (ProEngineer / SolidWorks) and GD&T.
  • Assessed product development life-cycle from designing through manufacturing and packaging phase including process development, layout and operation, etc. following cGMPs and CAPA.
  • Lead the utilization / management of the Design Controls (NPDP).
  • Interpreted and evaluated data from various engineering, research and/or marketing investigations to determine the performance requirements that will be incorporated into the product.
  • Designed new functional gages for the critical dimensions and modified the available gages to pass gage R&R.
  • Participated in approval of design reviews, deviations and engineering changes.
  • Worked with the regulatory departments to ensure project specification met the appropriate standards.

ConfidentialDelhi, India
Diagnostic Devices
Summer Intern

  • ­Worked on the manufacturing and testing of RVG Compatible and Conventional type X-Ray Machines.
  • Monitored new product identification, design, development, manufacturing implementation, documentation and sustaining engineering support of X-Ray grids and X-Ray sensors.
  • Coordinated and provided technical assistance in the production of prototypes.
  • Generated CAD models, drafted design and final drawings of products.
  • Worked closely with Process development to develop equipment and tooling for new product development.
  • Assisted in managing and selecting vendors for equipment and material; executing equipment set-up, calibration, training and SOP.

Confidential Delhi, India
Summer Trainee

  • Analyzed the manufacturing and working of precision Ultrasound devices and enhancing the sensitivity of the transducer probe.
  • Created, maintained, and executed PCB and system level testing of new and existing ultrasonic products.
  • Developed PCB and system level calibration as well as setup procedures for manufacturing and engineering.
  • Assisted in handling investigatory experiments with ultrasonic equipment to duplicate customer complaint issues.
  • Participated in new product development through prototype building, market research and literature review.


Confidential Newark, NJ
Master of Science (Biomedical Engineering)

Confidential New Delhi, India
Bachelor of Engineering (Biomedical Engineering)


  • Project Management Certification.
  • GD&T Certification.

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