Reliability Engineer (Indirect) (Professional)
Baker IT, Inc. - Littleton, MA

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Title Reliability Engineer (Indirect) (Professional) Description Design history file review to collect review and update as necessary risk assessment and Design FMEA documentation on existing market released devicesConfirm and document traceability between objective evidence documentation and MDD Conformity requirementsConfirm and document traceability between objective evidence documentation and EN IEC 606011 standard requirements and all relevant standardsAssure the timely accurate and independent evaluation of product performance and safety prior to clinical studies or market release Provide support for released products evaluate field performance and recommend corrective action when necessaryMay provide leadership to othersPrepare review and approve Qualification Plans and Reports for assigned projectsAssure the resolution of all issues raised by the testingPrepare review and approve Reliability Predictions for assigned projectsEvaluate 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 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 plansMaintain expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements Provide reliability engineering support of image guided systems through the product life cycle Participate in the reliability assurance of design manufacturing and testing of systems and components with an emphasis on electronic mechanical and electromechanical products Analyze field data for product improvement opportunity Basic Qualifications EDUCATION REQUIRED BSBA in Electrical Engineering or similar related field YEARS OF EXPERIENCE 5+ years of previous experience in a quality position in a regulated environment with BSBA SPECIALIZED KNOWLEDGE REQUIRED Well developed oral and written communication skills Experience working with crossfunctional designdevelopment teams Previous experience in managing multiple projects having multiple tasks DesiredPreferred Qualifications Working knowledge of FDA Quality System Regulations Medical Device Directive ISO 13485 ISO 14971 WEEE RoHS and IEC 60601 standards Knowledge of statistical techniques and reliability tools Proficient with data analysis Formal training in Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable Skills Education LevelUndergraduate Degree Industry Experience3 5 Years Reliability Engineering Experience3 5 Years Risk Management Experience 3 5 Years Education LevelGraduate Degree Industry ExperienceGreater than 5 Years Quality StandardsISO14971 IEC60601 Reliability Engineering ExperienceGreater than 5 Years Risk Management Experience Greater than 5 Years Six SigmaLean Sigma CertificationsGreen Belt Black Belt (RELIABILITY ENGINEER over 1.0 year(s) ) AND (DHF OR DESIGN HISTORY FILE ) AND(FMEA )