I have a comprehensive background in product development/project management within the confines of international medical device regulations. I thrive on taking vague ideas and ill-defined needs and turning them into concrete reality. I can start a medical device company from the ground up and I can do it on schedule. This includes... From a Regulatory perspective: --Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.) --Identification of applicable test protocols (ISO standards, etc.) and management of test houses --Interfacing with regulatory agencies and identifying consultants --Writing of regulatory submissions such as FDA 510(k)s --Quality System development and implementation to required standards (ISO 13485, FDA, CMDCAS, etc.) --Identification of loop holes and temporary workarounds to ease implementation pains and maintain profitability From a Project perspective: --Using good interpersonal skills to keep people motivated and excited --"Conducting the orchestra", developing a logical rhythm of events and ensuring timely completion of tasks --Turning "unknown unknowns" into "known unknowns", forseeing problems before they arise and altering the "orchestra" accordingly --Coordination of teams on an international level --Intelligently focusing energy on tasks with the highest variability, including procurement of additional expertise as necessary --Always keeping an open dialog about the day-to-day changes in the "Good/Fast/Cheap, pick any two but only two of the three" trade-offs in milestone achievement From a Product perspective: --Development of design parameters from organization input (Sales, Marketing, Support, etc.) --Nitty-gritty technical work like engineering drawings/drafting, statistical analysis, resdesigns due to manufacturing constraints, component supplier identification. --Identification, qualification, and day-to-day management of international manufacturers --Design History File/Technical File development and maintenance --Design Transfer for complex electromechanical devices From an Operations perspective: --Part Number/Drawing Number/Revision Control development and implementation --Engineering Change Order workflow and impacts --Purchasing-Manufacturing-Sales-Shipment procedures and throughput --ERP/MRP implementation including workarounds for system limitations I am a strong believer in a person's word. If I tell you I'm going to do something by a certain date that is my word and I'm going to get it done, hell or high-water. I don't mess around: I live on a remote homestead so I grow my own food, build my own structures, fix my own car, brew my own beer. My entire life requires a high level of precision execution every single day, failure is not an option.
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Badar Haider Agency Contractor
To provide value added services to my clients leveraging upon my 20+ years of experience in various facets of Finance, across industries and geographies, large corporations and SMEs and my academic qualifications... Also attaching my linkedin profile.. http://in.linkedin.com/pub/rajaram-srinivasan/8/5a5/864
Asher S. Agency Contractor
[Background] I have worked as a consultant to various companies worldwide in high-tech IT related sectors such as Cloud & SaaS, Mobile eCommerce, Automotive & more. [Vision] I believe in working with the best of the best. I am looking for new challenges where I'm given a chance to build something new, creative and completely mind blowing. [Expertise] Over the 14 year span of my career, I have accumulated expertise in the following areas: - New Product Development - Operations research & management - Social Media Marketing & Strategy - Business Development - Information Security - Big Data & Analytics - Mobile App Development - Start ups - Anything and everything cloud related - Software Architecture for large scale applications And of course, I am familiar if not an expert, in all technologies such as Java, Ruby, PHP, .NET, SQL, NoSQL, Unix, Linux, Windows, AWS, VMWare, Xen, Asterisk etc.
Sam R. Agency Contractor
The quintessential 'Agile' online executive is available to tackle your next project successfully with precision. 100% Unconditional Satisfaction Guarantee! As my Employer you can expect: * A highly skilled contractor at unconventionally low rates so you can minimize your budget and maximize your results! * A native English speaking professional who was raised and educated in the West with strong credentials so you don't have to worry about language, culture, or nuances! * A skilled and well qualified executive (MBA & M Sc.Eng.) so you can count on the work I do for you being done right the first time! * An established track record of performance. Nearly twenty years at two of the top Companies on the Planet. (Big 5 Management Consulting, Far East Energy Conglomerate) So you know that I actually can do what I say I can! * A superior command of Global Best Practices that can be applied to your Organization. People, Process, & Technology. So that you know you'll get someone who is flexible and adaptive. * Focus on Quality, Innovation, Performance, & Excellence. So you'll get a commitment to growth! * A superior command of Business Needs & Technology Enablement so you will get a team player with Cross-Functional experience in delivering pragmatic solutions on-time and on budget! * An accurate Profile and Tests that have been completed without reference materials. Go ahead! Try me. I'm up to the challenge! *Availability to work on a Pro-Bono or reduced rate basis for qualified non- commercial Worthy Causes (Social Impact, Charitable). *Excellent Connectivity across Win 7 and Mac OSX Platforms including fully equipped home offices in Hong Kong, Karachi, and Singapore. I travel twice a month (off-time) between cities but remain online 100% through devices.
I am fluent in English Language. 1. Delphi 3 - XE7, Firemonkey Win32/Win64, MacOSX, IPhone, Android, Datasnap, DevExpress and all major thirdparty components, Customized Controls Development, C++ Header Conversion, Windows API, COM, ActiveX. 2. Visual Studio: C#, VB, ASP.net, WCF, Silverlight, WPF, Entity Framework and all major thirdparty components. 3. Upgrade from Old IDE versions to New versions. 4. Migration from Delphi to/from .Net and other languages. 5. SQL: SQL Server, Oracle DB, Oracle Forms, MS Access, MySQL, SQLLite, PostgreSQL, Intersystems Cache etc. 6. ERP, Manufacturing System. 7. Systems Programming, Cloud Computing. 8. GUI and Graphics designing. 9. Web sites, Web Applications, HTML, CSS.
Seasoned IT Professional with extensive experience in Software Development, Database Technology, Project Management & Business Analysis. An innate ability to always remain on top of the situation has helped me to establish a track record where I have not missed out on a single deliverable. Core Technology Areas - Data Warehousing & Business Intelligence Tools - SSIS, SSRS, SSAS, Crystal Reports - Development of Triggers, Stored Procedures using T-SOL in MSSQL Server - Designing databases - Conceptual & Physical schema - .Net framework 3.5 & 4 - Asp.net, Web Worms, C#, Ajax, Web Services, Win Forms - ORM- LINQ, Entity Framework. nHibernate - Use Cases, UML Artifacts, MS-Visio, Wireframing tools - MS-Access, VBA Abilities - Orchestrating total solutions from requirement analysis to testing and implementation. - Proven experience in project management, risk analysis & successfully leading teams - Interfacing with clients - both pre & post sales Strengths - Ability to think out of the box within defined and accepted methods of execution and delivery
Professional Translator. Professional Business and Technical Translation Expert. Best Skills on Simplified Chinese, Traditional Chinese translation. Good Culture Background knowledge : China Mainland, Hong Kong, Taiwan and Singapore. Best Skills on Marketing and Outbound Sales Best Network and Resource to Expand Your Business in China mainland. Include Online Business Promotion & Offline Business, Such as All Kinds of Out-Sourcing Marketing , iOS or Android App marketing and etc. Low Cost, High Quality Customer and Considerable Market Share Get For You. Market Research Expert for Web Research, Sourcing, Cold Calling Help you to find most valuable information and supplier in China. A Good Sourcing Agent in China. Customer Service Expert A Best Virtual Assistant. Best Assistant to Localize Your Business in China Mainland & Hong Kong. Database Expert, Best Skills on SQL Server 2012. Business Intelligence Professional