SUMMARY

Over 17 years of successful strategic and tactical leadership in information systems, consulting, and business development. Proven leader who maximizes people and processes. Excel in getting teams executing on the strategy and creating momentum that results in winning. Experience in Software Development Life Cycles SDLC in software for medical devices and SOA enterprise applications MES . Experienced in client facing consulting roles such as Program Manager, Solution Architect and Technical Lead. Technical skills include requirement gathering, technical specification definition, system/application architecture, design and development, process modeling and configuration and in/out source task assignment with updates to clients technical and executive . More than 8 years of Project executions in Medical device, Bio Tech, Pharmaceutical and Semiconductor industries.

CORE COMPETENCY

• Roles: Program Manager, Solution Architect, Tech Lead, Software/hardware Engineer, Verification and Validation V V Engineer.
• Languages: Microsoft .NET VB.NET, ASP.NET , C Beginner and JavaScript, C, XML, XSLT and HTML
• Databases: SQL2008 and Oracle 10G. Experience with SQL Developer and Toad. Perform backup, restores, migrate Tables, Functions, Stored procedures. Author stored procedures and consider optimization techniques.
• Software Experience: Manufacturing Enterprise systems MES configuration and development of GUI web pages , integration to JDE, Embedded Software, National Instruments: Labview for Automated Data acquisition and control, Motion Control, Image Acquisition and Processing IMAQ and Measurement and Analysis.
• Software: GE SOA Proficy Workflow, Camstar InSite, JD Edwards MES integration , Telelogic DOORS
• OS: Windows: Windows 7, Server 2008, Linux: Slackware, manage and maintain various virtual environments such as Virtual Box, VMware and Virtual PC.
• Applications: MS Office, OneNote, Project, Visio, Visual Studio 2010, Infragistics, Balsalmiq, Eclipse Development tools, Tortoise Subversion or SVN version control , Bugzilla Bug/issue tracking , PVCS, SourceOffSite Repository.
• FDA Compliant Environments:
• Successfully completed following activities for products: Left Ventricular Assist Device LVAD , Glucose Monitor, Catheters, Interface Programmer System and Blood analyzer systems.
• 1 Validation of software systems as per 21 CFR Part 11,
• 2 Hazard analysis EN 60601-1-4 and EN 14971 ,
• 3 DMR GAP Analysis as per 21 CFR Part 820,
• 4 Failure Mode and Effect Analysis FMEA
• 5 Medical Devices Current Good Manufacturing Practice CGMP

EXPERIENCE

Confidential

Position: Solution Architect

Activities:

• Architecting and justifying technical solutions to complex business requirements.
• Responsible for implementation of the policies, procedures, best practices, tools, techniques, and deliverables.
• Ensure well-being of the project through Customer management Stakeholder level contact, maintaining Customer satisfaction, and reporting of the project status.
• Project Management Discipline apply project management experience, managing many large scale projects in operations and technology, applying discipline and structure that drive positive results.
• Leadership strong integrity, passion, and motivating ability to encourage individuals and teams to take hold of and achieve success.
• Identify and capture solution requirements. Interpret business requirements. Work with Cross Functional teams to gather requirements and consensus. Craft the proposed solution for the requirements and gains the Customer's agreement through documentation, prototyping, and presentations.
• Review the build deliverables to ensure conformance to the proposed solution this includes design documents, prototypes, test scripts, and test execution.
• Document and review software requirements for collaboration with local client teams and offshore teams company partners .
• QA Activities: Write Test Plans, perform Unit testing and code reviews.
• Author Best Practices for software development and ensure team members adherence.
• Adhere to strict QA principles that reduce software related issues, avoid scope creep and deliver software per requirements.
• Additional responsibilities include provide implementation support, technical training, mentor team members and assist in product conversion/update configuration. DB Backup and restore, migration SQL Tables, Functions, Stored Procedures.
• Perform QA tests and documentation for re-usable components that can either be part of product suite or individual licensed features.

Confidential

Position: Solution Architect/Technical Lead

Activities:

• Responsible for the overall architecture of the solution for a project from a functional viewpoint and represent in the implementation phases of projects. Architecting and justifying technical solutions to complex business requirements.
• Experienced with 4-Tier Service Oriented Architecture SOA that have inter Tier communication over XML. Experienced in Enterprise solution consisting of webservices for the web application and WCF for portal services.
• Identification of additional sales opportunities for the project, to be addressed by the Sales group.
• Responsible for implementation of the policies, procedures, best practices, tools, techniques, and deliverables.
• Establish, promote, and represent the interests of the Customer and resources for the project. Resources include personnel, equipment, and materials.
• Ensure well-being of the project through Customer management level contact, maintaining Customer satisfaction, and reporting of the project status. The project status includes the costs, and schedule.
• Identify and capture solution requirements. Interpret business requirements, advice on FDA compliant DHR's. Work with Cross Functional teams to gather requirements and consensus. Craft the proposed solution for the requirements and gains the Customer's agreement through documentation, prototyping, and presentations.
• Review the build deliverables to ensure conformance to the proposed solution this includes design documents, prototypes, test scripts, and test execution.
• Configure and develop custom code and web forms using .NET in a high volume and availability web application SOA to meet client requirements.
• Document and review software requirements for collaboration with local client teams and offshore teams company partners .
• QA Activities: Write Test Plans, perform Unit testing and code reviews.
• Author Best Practices for customization and software development and ensure team members adherence.
• Manage teams during project to meet project deadlines, adhere to strict QA principles that reduce software related issues, avoid scope creep and deliver software per requirements.
• Additional responsibilities include provide implementation support, technical training, mentor team members, publish technical manuals and assist in product conversion/update configuration.
• Provide input and support for MES reports and interface data exchange.
• Perform QA tests and documentation for re-usable components that can either be part of product suite or individual licensed features.

Confidential

Positions held: Lead V V Engineer, Lead Project Engineer, S/W H/W Design Engineer

Activities:

• Interpreting product requirements, performing Hazard analysis, develop Verification and Validation plan and test protocols, perform gap analysis for DMR Device master record and documentation for 510K Submission to FDA.
• Perform Unit testing and code reviews. Perform regression testing.
• Engineering responsibilities include:
• Software programming, troubleshooting, hardware test and debugging along with integration of external devices.
• Perform audits to comply with FDA 21 CFR Part 11 requirements. Manage and maintain all lab equipment's.
• Develop hardware prototypes.

Confidential

Position: Manager

• Managing patient demographics, billing, collection and administrative tasks.
• Documenting medical practice reports, test results, and medical narratives.
• Manage offshore teams to get medical documentation and other activities performed.

Confidential

Position: Research Assistant

Responsibilities include Automation of measurement and data acquisition of lab instruments using Labview. Perform semiconductor parametric testing and transistor lifetime measurement. Program in VHDL for ASIC design, chip layout, timing analysis, power analysis, design rule check and simulation.

Confidential

Automation/Test Engineer

Responsibilities include develop an Automatic vision inspection for fiber optic end face measurements, a Motion control system for scanning production optical filters for test, measurement and quality checks and Data acquisition and control system for real time in situ measurement of optical filter characteristics during deposition.

Confidential

Responsibilities include creating user centric design development and solutions, developed technical application notes, brochures and trade show presentations. Prepare and process request for quotes RFQ and orders. Research new applications for product line. Help marketing team with brochures, web information and technical support.

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