- 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
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
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
- Identified and evaluated vendors to support product development.
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
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.
- 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.
- 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.
- 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
- 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.