Sumit Rana

Dynamic and Results-Oriented Professional

r7a1lo@r.postjobfree.com

Cell 619-***-****

Current Address

*** ***** * ******* **** N

Harrison NJ 07029

USA

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.

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Experience

Spine Wave Inc. Shelton, CT 02/2012 – Present

www.spinewave.com – 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 rapid 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.

UniLife Corporation York, PA 09/2011 – 01/2012

www.unilife.com – 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 designs in 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.

Stryker Orthopaedics Mahwah, NJ 03/2011 – 09/2011

www.stryker.com – Surgical Implants and Instruments

¬Product Design Engineer (Contractor)

• 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 with Windchill Enterprise Content Management System (ECM), Supplier Production Part Approval Process (SPPAP) and converting Unigraphics Models into Pro/E models.

• 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.

Becton Dickinson & Co. Franklin Lakes, NJ 06/2010 – 03/2011

www.bd.com – 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.

New Jersey Institute of Technology Newark, NJ 08/2009 – 05/2010

www.njit.edu – 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.

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Amazon Consultant Engineers Delhi, India 09/2006 – 07/2008

www.gomax.co.in – 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.

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Amazon Consultant Engineers Delhi, India 05/2006 – 08/2006

www.gomax.co.in – 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.

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Siemens Medical Solutions Delhi, India 05/2005 – 08/2005

www.siemens.co.in - 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.

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Education

New Jersey Institute of Technology Newark, NJ

¬Master of Science (Biomedical Engineering)

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¬Maharshi Dayanand University New Delhi, India

¬Bachelor of Engineering (Biomedical Engineering)

Certifications

• Project Management Certification.

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