Principal Reliability Engineer
Baker IT, Inc. - Northridge, CA

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Title Principal Reliability Engineer (Indirect) (Professional) Looking for a Reliability Engineer (either Mechanical or Electrical) with excellent analysis and troubleshooting skills of electromechanical devices This Engineer will work closely with Sr Level Technicians in the analysis of returned product to determine root cause of field failures This Engineer must also be able to make implementable recommendations to management through both oral and written communication Description Design history file review to collect review and update as necessary risk assessment and Design FMEA documentation on existing market released devices Diagnostic and therapeutic medical devices and device programmers Provide support for released products evaluate field performance and recommend corrective action when necessary May provide leadership to others Prepare review and approve Qualification Plans and Reports for assigned projects Provide technical support for technicians performing the testing Assure the resolution of all issues raised by the testing Prepare review and approve Reliability Predictions for assigned projects Review and approve changes to products in production for reliability impact to aid in the correction of process design or materials problems Evaluate field performance of assigned products by reviewing field data supporting technicians to evaluate unusual returns and supporting Technical Services and Consumer Affairs in responding to customers Support Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA Investigates and evaluates product field problems This includes preparing Product Field Impact Reports and Health Hazard Analysis and working with Marketing Product Development and Regulatory on field action plans Maintain expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements Take on special projects in which only the results are specified and complete them on schedule This may involve making presentationsrecommendations to management May supervise technicians andor engineers Skills Education LevelUndergraduate Degree High School Diploma or Equivalent Industry ExperienceGreater than 5 Years Oral CommunicationExcellent Facilitation Skills Reliability Engineering ExperienceGreater than 5 Years Software Application KnowledgeEngineeringAcrobat Reader MS Exchange MS Outlook MS Visio MS Word MS Access MS Excel MS PowerPoint MS Project Written CommunicationExcellent Education LevelMaster of Science Software Application KnowledgeEngineeringSoftware Application Knowledge wwwBakerITcom (RELIABILITY ENGINEER over 5.0 year(s) OR ELECTRICAL ENGINEER OR MECHANICAL ENGINEER ) AND(DFMEA ) AND (MEDICAL DEVICE )
About this company
Since 1993, Baker IT has been a leader in providing technology resources to help our clients gain competitive advantage by employing the...