Summary

• 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.

Experience

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
Ultrasound
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.

Education

Confidential Newark, NJ
Master of Science (Biomedical Engineering)

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

Certifications

• Project Management Certification.
• GD&T Certification.