Engineer System

EMMANUEL NISHANTH

**** ***** ******, *** **** Phone: 443-***-****

Sunnyvale, CA 94086 E-mail: *********@*****.***

SUMMARY

Strong cross-functional experience in leadership & core contributor roles in various phases of New product development (NPD) life cycle ranging from concept through technical development/assessment to Verification and Validation of complex integrated systems for biomedical device applications. Strong background in Technology management, System Integration, System trade off and gap analysis to derive System Requirements/Specifications. Technical expertise in Optical-electrical-mechanical system design including software-hardware interface, algorithm development and a strong capability for data processing, analysis and making conclusions using statistical tools.

ACHIEVEMENTS

* Led the development of a proof of concept miniature glucose meter Instrument system with low-cost optical components duplicating performance of a high cost Optical system through internal and external collaboration efforts. This achievement was a milestone for the reduction of a key risk for the project.

* Translated product functional requirements into product design specifications for a handheld consumer based miniature optical detection medical product by developing the total system signal budget through risk assessment and system design trade off analysis.

* Managed external design houses to develop next generation Instrument prototypes in order to deliver on project milestones.

* Resolved critical performance issues from multiple diagnostic assay systems through rigorous data analysis & simulations in MATLAB. The result of this effort helped improve the sensitivity/specificity of the assays.

PROFESSIONAL EXPERIENCE

St. JUDE MEDICAL, SYLMAR/SUNNYVALE, CA

Clinical Systems Engineer (2010–Present)

Cardiac Rhythm Management Division (CRMD)

* Coordinated a strategy working with cross-functional stakeholders to validate and improve complex electromagnetic simulations of Magnetic Resonance Imaging (MRI) compatible pacemaker system designed to prove safety of use in Regulatory submissions.

* Developed requirements and validation criteria to ensure that the electromagnetic simulations represent actual physical conditions.

* Developed system use cases, clinical workflows & system state diagrams to develop power budget and facilitate hardware-software integration for a next generation Patient implant monitoring system.

* Integrated efforts from various cross-functional stakeholders to finalize hardware components for the next generation Patient implant monitoring system per user requirements.

* Delivered on Process Initiative to optimize Verification, Integration & Validation (VIV) processes on a department wide scale.

BECTON DICKINSON & COMPANY

Engineer R&D (2006–2010)

BD TECHNOLOGIES, RTP, NC

Core contributor with various cross functional teams for the technical assessment and development of various cutting-edge technologies ranging from single analyte/multi-analyte detection technologies, microfluidics, In-Vitro Diagnostics (IVD) and Continuous Glucose monitoring (CGM) applications.

* Developed software controlled Optical instrumentation systems that were used for pre-clinical testing and the Human clinical of a proprietary chemistry for an Optical based Continuous Glucose Monitoring Technology.

* Designed and developed Opto-mechanical instrument systems for various projects involving the detection of biomarkers in various sample formats for use in In-Vitro Diagnostic (IVD) applications. These systems were used by other chemical engineers to develop & optimize proprietary IVD assays to achieve project milestones.

* Authored protocols and associated documentation to optimize processes in the scale up of sensor production from research phase to pilot manufacturing capability.

* Interacted with Regulatory & Quality functions to deliver Instrumentation & software including the development of the Design Input Specifications (DIS) for use in Pre-clinical and Human Clinical trials.

BECTON, DICKINSON & COMPANY

Engineer R&D (2004–2006)

Diabetes Care, Advanced Product Development, Sparks, MD

Core contributor as part of a cross functional team for the development of a Low cost, hand held, battery operated instrument for a proprietary Optical chemistry for a Continuous Glucose monitoring (CGM) application from concept to product definition.

* Translated user requirements into System functional requirements.

* Developed the architecture and System Requirement Specification(SRS) of the Optical system for a low cost, hand held, battery operated, wireless consumer Optical continuous glucose meter including final cost estimates (BOM) of a manufacturable final product.

* Led the development of Optical detection system for sensor test beds and clinical trials. This system was used by other chemical engineers to produce thousands of prototype sensors which facilitated the development of the proprietary chemistry for Continuous glucose monitoring into a product embodiment.

* Developed a vendor matrix based on their strengths and technical capabilities for the manufacture of a miniature Optical fluorescence reader product. This involved interaction and scouting technologies/capabilities from different vendors/suppliers.

UNIVERSITY AT BUFFALO

Graduate Research Assistant (2002-2004)

The Institute for Lasers Photonics & Biophotonics, Buffalo, NY

* Developed a highly sensitive optical fiber sensor technique to detect molecules in very small concentrations as part of Graduate thesis including immunoassay development and antibody labeling.

MEGASOFT Ltd, Chennai, India.

Systems & Network Administrator (2000-2001)

* Provided systems engineering, software engineering, technical consulting and administrative services as a member of the Systems and Network Database Group.

SOFTWARE/HARDWARE

Microsoft Office, Matlab, Lab view, Minitab, Pro-Engineer & Zemax. Experience with LEDs, Diode Lasers, Optical filters, fiber optics, photodiodes, CCDs & PMTs, data acquisition systems.

EDUCATION

Master of Science in Electrical Engineering, University at Buffalo 2004

Graduate thesis: Rakesh Kapoor, Navjot Kaur, Emmanuel T. Nishanth, Earl J. Bergey, Stanley W. Halvorsen & Paras N. Prasad. Detection of trophic factor activated signaling molecules in cells by a compact fiber-optic sensor. Vol. 1, Issue No. 2, Pages 345-349. Journal of Biosensors & Bioelectronics.

Bachelor of Technology in Electronics & Communication 2000

Pondicherry Engineering College at Pondicherry, India

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