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Posted by: CCSI Inc- Robert Ryder <robert@ccsiinc.com> on September 18, 2009 at 08:56:39. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Contract
City: Mounds View
State: Minnesota
Country: United States

22498 - Provide reliability engineering support of market released non-implantable instruments and patient management (software) through the product life cycle. Support reliability improvements through education and communication of existing field issues/concerns across the CRM organization. Support cross-functional teams in the preparation of Reliability/Risk Assessments: reliability predictions, Hazard Analyses, Fault Tree Analyses, FMEAs, etc. Evaluate field performance, analyze field performance trends, and recommend corrective action when necessary. Support Return Products in analysis and evaluation of field returns. Investigate and evaluate field issues with respect to potential health risks (perform Corrective Action and Preventive Action activities and prepare Health Hazard Analyses) and work with teams to resolve; also work with Marketing, Product Development and Regulatory on field corrective action plans. Prepare Product Assurance Plans, Qual/Test Plans and Qual/Test Reports. Provide technical support for technicians performing testing. Assure resolution of all issues raised during testing. Define, champion and integrate all testing, including the continuum of DVT, qualification, validation, etc. Use reliability testing to understand design/process margins. Review and approve changes to designs/processes and assess impact on product and qualification status. Provide input for Regulatory submissions. Support MQA/QA in the disposition of discrepant material/processes and in the qualification of new material/ processes to assure reliability requirements are met. Provide design input by reviewing legacy product performance and assessing new technologies. Participate in establishing and reviewing specifications/requirements for component, product and processes. Review changes to designs and processes and assess impact to assure reliability requirements are met. Understand integration of component, design, and process to ensure adequate design/process margin. Establish project reliability/quality goals and metrics to drive continuous improvement. BS in engineering or related field. At least 3 year of experience in Reliability, Design Assurance, or Product Assurance. Experience with structured project management Demonstrated problem solving and critical thinking ability. BS in engineering or related field. 5 years experience in Reliability, Design Assurance, or Product Assurance. Proficiency with data analysis using statistical techniques and reliability tools. Excellent written and oral communication skills. Experience with structured project management Demonstrated problem solving and critical thinking ability. Experience working with and providing direction for cross-functional teams.