eConsultAmerica is a preferred vendor supplier on retainer with a major global supplier of health products with the oldest, best known and most respected health products in the world. Our client is seeking an experienced and savvy Principal Engineer who will lead and participate in all systems engineering activity for design maintenance and design enhancements on a medical device. This position will be based in St. Louis, MO. Full relocation Package will be offered. If you are interested please forward a brief cover-letter and your updated resume and I will respond back within one (1) business day. US Citizens or Green Card holders only apply. Contact InformationeConsultAmericaThe IDS Center80 South 8th Street, Suite #900Minneapolis, MN 55402888-902-3999 (Office)612-886-2368 (Cell) - EmaileConsultAmerica - Yahoo Instant Messenger - Skype Instant Messengerhttp://www.eConsultAmerica.com - WebsitePosition DetailsThe successful candidate will lead and participate in all systems engineering activity for design maintenance and design enhancements on a medical device. The chosen candidate will create, maintain and communicate a plan and schedule in Microsoft Project for completion of all technical tasks, including documentation, verification, and validation of requirements. Plan and lead the integration of sub-systems into a completed system that conforms to all subsystem and system level requirements. Maintain the system product requirements and technical requirements. Lead the design change control process for the product, maintaining meeting agendas and minutes and provide the voice of the technical team on the project core team. Lead root cause analysis and troubleshoot on complex system level product failures. Coordinate testing in support of certification to IEC 60601-1 and collateral standards during design verification and write system level design verification summary reports. Maintain and track all physical assets of program under appropriate levels of configuration management for design verification, clinical field activity and troubleshooting. Lead the creating of and maintenance of the system architecture, including all system diagrams, block diagrams for the system and the interface control document. Deploy critical parameter management where appropriate to ensure the system design is robust and capable. Create, maintain and update reliability block models and drive and document the execution of reliability testing. Maintain and communicate key information, including the key decisions list, the current technical issues list and the current technical product risk lists. Maintain and update DFMEA and risk analysis, currently in Excel, in response to design changes and drive updates appropriately. Maintain updates to the Design History File and index. Move requirements and tracing from current structure into Requisite Pro.BEST INDUSTRY - Bio-Tech, Medical Device, Pharmaceutical Department- Research & Development
Experience: MS in Electrical, Mechanical or Software engineering or a BS in one of these three areas along with a proven track record in medical product development is required. 5 - 10 years of IT experience.Medical device product development experience within a structured product development process, including systems engineering lead activity is essential in this role.Compensation80K - 125K

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