Expert Details

Expert in E-beam Imaging Product and Material Development, Laser, FDA Radiation and Product Safety Compliance

Expert ID: 726285 California, USA

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Expert is a well-qualified professional with more than 15 years of experience in designing electronic products and materials for high kV electron beam and x-ray imaging applications . He has got extensive knowledge in image processing and analysis of the data obtained from analytical instruments used in nanotechnology and biotechnology. He is a Project Lead with highly competitive technical and team management experience. He possess in-depth experience of product design, regulatory compliance, product development cycle and technology. He has authored and presented reports, procedures, publications, and presentations to working groups, agencies, journals, seminars, and conferences.

His core competencies are-
•High kV Electron beam and X-ray Imaging Products Development
•Semiconductors, Magnetic, Scintillation Materials, Radiation shields,Pb-free Materials Research
•Radiation Physics
•Microscopy Product Systems Engineering
•Radiation Safety Program Development and Management
•Laser Safety Program Development and Management
•Chemical Safety Program Development and Management
•QA /Product Validation/Compliance Engineering
•RoHS/WEEE/REACH/METI Process Implementation
• Export/ECCN/ITAR Compliance Program Management
• PLC/Program/Project Management

Expert's expertise in Imaging Product Development resulted in the introduction of five new products in the market (each product costs from $100K to $250K) and enhances the client's company growth 15% per year consistently. His expertise in the Regulatory Compliance Engineering, externsive knowledge in the Product Safety directives, laws, regulations and standards has provided clear direction and long-term plan for penetrating and capturing the international market successfully. The compliance engineering product design and approval process developed by him accelerated the product development phase and as a result, the products were introduced in the market in advance. His process development for cross-functional teams resulted in easier product management and product issues in the field were resolved amicably with less hue and cry.

Expert's another area of expertise is in Environmental, Health and Safety (EHS) Compliance. He has developed, implemented and maintained Radiation, Laser and Chemical safety program of the entire R&D and customer demo labs (6+) and trained 100+ Engineers at client's site. He has developed, implemented and maintained EHS compliance policies, standards, programs and procedures for entire organization He conducted and coordinated site safety, code compliance, and environmental compliance audits resulted in zero complaint.He has facilitated compliance with NRC, OSHA, and US state regulations and standards at client's site. He has prepared radiation test reports, technical documents, standard operating procedures, based on regulatory requirements and best management practices. He has developed Calibration of Radiation detectors and implemented dosimetry program. Also, he has maintained registration of radiation producing machines and radioactive materials at the client's site.


Expert is an experienced Materials Scientist. His research for finding the alternative materials for Pb has been used in the Radiation Shielding design for high kV electron beam products and x-ray imaging products. Also, he has developed Pb-free materials for PCB soldering. These changes have affected in producing the environmental friendly products and the products passed Environmental Regulations such as RoHS and WEEE. His materials expertise in semiconductors and magentic materials preparation and characteristics led into alternative magnetic devices for magnetic storage and other semiconductor devices application.

As a Product Validation Expert working on behalf of a California company, he identified necessary hardware design requirements for incorporating them into design process of Lumina XR and microCT imaging systems. He implemented biomedical instruments design standards (FDA, PTB, EN954-1, DIN 54113-2, EN60204, EN 60529, EN 61010, NFC 74-100), European Directives and international regulations. He also determined global approval requirements and obtained approvals from international regulatory agencies, established global export requirements and obtained licenses for product Sale and Installation Services.As a Compliance Expert on behalf of a California company, he classified and validated all imaging and analytical product lines under the specifications of the Export Control Classification Number (ECCN) process and ITAR process. He created Product Life Cycle (PLC) Compliance Design Check List (CDCL) and implemented the design changes during the product development cycle reduced manufacturing costs by 30%. He implemented global regulatory approval (FDA/CDRH, SEMI-S2, CE, PTB, EURATOM, ROHS, WEEE, REACH) process and obtained global approvals for 9+ Imaging Products enhanced the product marketing and sale globally by 50%. He customized Oracle Agile PG&C PLM software tool during the implementation and managed the compliance data that needed for cross-functional teams. He developed and maintained ionizing Radiation, Laser and Chemical safety program of the entire R&D and customer demo labs (6+) and trained 50+ Engineers. He established and maintained Compliance Engineering sharepoint web-site and increased the visibility of Engineering activities by 90%. He interacted with cross-functional teams for developing and implementing Compliance Engineering process SOPs across the whole organization.
As a Systems Engineering Expert on behalf of a California company, he successfully solved problems discovered in the field by designing and implementing solutions by driving projects through the appropriate engineering departments. He designed and delivered CIP solution to provide process characterization and field support for a significantly large install base (more than 100 systems). He coordinated in developing specs, camera compatibility, electron microscope and camera interference and product configuration with five major OEMs and increased the sale by 50%. He prepared Engineering Change Order (ECO), Bill of Materials (BOM). SOPs, DoCs for release.
As a Product Development Expert on behalf of a California company, he managed design team in creating a design and development project for imaging equipment Image intensifier and CCD-design, increased process efficiency and product quality by 20%. He coordinated with Field Service, Sales and Customers for alpha and beta specs evaluation.
He successfully resolved the camera compatibility, electron microscope interference and product configuration issues and enhanced the business by 25%.He designed and tested radiation shields for 10keV to 1 MeV electron microscopes. He established a new in-line process development project by utilizing epoxy for CCD and fiber optics bonding, production rates, and efficiency while decreasing operating costs by 30%. His identification of new scintillators and coating materials led to development of the five new imaging products (UltraScan and Orius models) with enhanced performance. He designed excellent product development test process enabling a reduction in R&D and implementation costs $100K per year.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 2001 Degree: Ph.D. Subject: Electronic Engineering Institution: CUHK, Hong Kong
Year: 1992 Degree: M.S. Subject: Physics Institution: Madras University
Year: 1990 Degree: B.S. Subject: Physics Institution: Bharathiar University

Work History

Years Employer Title Department Responsibilities
Years: 2010 to Present Employer: Undisclosed Title: Product Validation Consultant Department: Responsibilities: He has identified necessary hardware design requirements for incorporating them into design process of XRay and microCT imaging systems for a Life Sciences/Medical Devices Company client. He has implemented Medical Device design standards (EN954-1, DIN 54113-2, EN60204, EN 60529, EN 61010, NFC 74-100) and regulations. He has determined global approval requirements and obtained approvals from US FDA and other international regulatory agencies. He has established global export process and obtained licenses for product Sale and Installation Services.
Years: 2001 to 2010 Employer: Gatan Inc Title: Project Manager /RSO/LSO Department: Responsibilities: He has developed and maintained Environmental Health and Safety (EHS) Compliance.
He has developed and maintained Imaging and Analytical Product Regulatory Compliance Program. He has developed Imaging Products for electron beam instruments. He has developed and maintained a team for Sustaining Engineering and Product support.
Years: 1997 to 2001 Employer: CUHK Title: Research Scientist Department: Department of Electronic Engineering Responsibilities: He has designed and fabricated nanometer scale magnetic layers in semiconductors using ion implantation techniques. Evolution of Fe-rich precipitates in Ge, Si and GaAs was obtained by surface characterization techniques. Superparamagnetic nature of the Fe nanoclusters (~4 nm) was determined using Superconducting Quantum Interference Device (SQUID) magnetometer by him. He studied Microstructure and chemical bonding between magnetic materials and semiconductors by X-ray Photoelectron Spectroscopy (XPS). Giant Magnetoresistance (GMR) of the implanted layer was measured (8.6% at 300K and up to 76% at 140 K)) using the four-point probe method.
Years: 1995 to 1997 Employer: Indian Institute of Technology, Chennai Title: Research Associate Department: Department of Physics Responsibilities: He planned and conducted research on electrical resistivity of superconductors upon illumination of LASER. He maintained liquid nitrogen and helium plant. He was a Tutor for B.Tech and M.S. students class-room and laboratory engineering course.
Years: 1994 to 2005 Employer: Saha KEIL Limited Title: Quality Assurance Engineer Department: Responsibilities: He has developed and implemented statistical process control (SPC) of metalized plastic film and AC polypropylene capacitors. Quality analysis was performed using seven QC tools. He developed SOPs and obtained ISO 9002 certification. He participated in cross-functional teams to improve product quality by reducing defects, cost and cycle time.

International Experience

Years Country / Region Summary
Years: 2008 to 2008 Country / Region: South Korea Summary: He has given Radiation Safety Training to a group of Field Service Engineers for Asia. He has done the installation and evaluated the radiation safety of the product.He has given training to the Engineers how to conduct the radiation test, operate the radiation detectors and do the data analysis.
Years: 2007 to 2007 Country / Region: Spain Summary: He has given Radiation Safety Training to a group of Field Service Engineers for Asia. He has done the installation and evaluated the radiation safety of the product.He has given training to the Engineers how to conduct the radiation test, operate the radiation detectors and do the data analysis.
Years: 2004 to 2004 Country / Region: Japan Summary: He has given Radiation Safety Training to a group of Field Service Engineers for Asia. He has done the installation and evaluated the radiation safety of the product.He has given training to the Engineers how to conduct the radiation test, operate the radiation detectors and do the data analysis.

Career Accomplishments

Associations / Societies
HPS
Licenses / Certifications
Radaiation Safety Officer Certification,
Laser Safety Officer Certification
Publications and Patents Summary
He has authored 6 articles in peer-reviewed publications.

Additional Experience

Expert Witness Experience
As a Radiation Safety Officer, he was consulted by California Department of Public Health (CDPH) for the work-place radiation safety complaints.

As a Radiation Safety officer and Product Engineer, he was consulted by independent legal counsel regarding the product safety.
Training / Seminars
Developed and designed annual Radiation and laser safety class room/hands-on training course materials and conducted annual training to hundreds of Service personnel, lab users and customers.

Developed European Union RoHS/WEEE implementation process and given training to Electical, Mechanical, and Manufacturing Engineers.

Developed Chemical Safety Program, Chemical Authorization process and given training to key stakeholders and chemical users
Vendor Selection
Expereinced in finding the CCD vendors and fiber optic plate coaters. Experienced in managing the 3rd party Compliance test labs and contractors for Compliance Program implementation.
Marketing Experience
Qualified to analyse the electronic products industrial trends in the area of Environmental Complaince Regulatory requirements in Japan, China, Korea, Australia and Europe. Qualified to validate the electronic products developed for biotechnology, nanotechnology and healthcare applications.
Other Relevant Experience
SOFTWARE APPLICATIONS SKILLS-Codes: TRIM, SRIM, IBA, MCNP, EGS4, ResRad, Microshield, Remit; Languages: C, C++, Fortran; Data and Image Processing: Matlab, MS Origin, SigmaPlot; Operating Systems: Windows and Unix; Other: MS Office, MS sharepoint, Crystal View, M2M, Filemaker Pro, Web-Ex, Oracle Agile.

TECHNICAL CAPABILITIES

• Image resolution and sensitivity measurements of the CCDs (Ultra Scan and Dual View)
•Radiation measurements: Proportional and GM Counters, Scintillation Detectors, TLDs
•Ion implant process and equipment expertise: Few keV ion implantation (MEVVA JYZ-8010) and MeV ion implantation (Hi Voltage)
•Evaporation and E-beam metal deposition process and equipment expertise (Edwards and Varian)
•Analytical equipments expertise: AFM, RBS, PIXE, AES, XPS, TEM, SEM, XRD and SQUID

Language Skills

Language Proficiency
Tamil Excellent
Telugu Good

Fields of Expertise

advanced material technology, analytical testing, atomic-force microscopy, bremsstrahlung, compliance engineering, compliance testing, electrical product safety, electron microscopy, environmental compliance, Environmental Protection Agency compliance, Food and Drug Administration laser safety regulation, gamma-ray detector, imaging science, laser safety, materials engineering, materials science, microstructure analysis, nanocomposite, personal protection equipment, portable X-ray machine, product compliance, product evaluation, product safety, radiation damage, radiation effect, radiation risk assessment, radiation safety, radiation sensitivity, radiation shield, safety compliance, safety inspection, safety procedure, semiconductor material characterization, semiconductor processing equipment, soft X-ray, surface analysis, transmission electron microscopy, X-ray absorption, X-ray detection, X-ray emission, X-ray equipment, X-ray measurement, X-ray physics, X-ray protection, X-ray shielding, nanomaterial, analytical science, public safety, health safety, equipment safety, compliance, workplace safety and security, laser safety regulation, global regulatory procedure, X-ray detector, Food and Drug Administration compliance, product approval, protection, laser safety training, beta ray, laboratory safety, lead equivalent, safety data collection, European standard, safety design review, advanced material, material application, machine safety, materials science modeling, quality improvement, materials safety data sheet, atomic force microscope, coating material, X-ray tube, X-radiation, photon, analysis technique, printed warning label, radiation safety code, National Fire Protection Association code, gamma ray, electron

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