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Terumo BCT Engineer 4 in Lakewood, Colorado

Engineer 4 Please wait...Date: Nov 5, 2020Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 26741At Terumo Blood and Cell Technologies, our 7,000+ global associatesproud to come to work each day, knowing that what we do impacts the lives ofpatients around the world.We make medical devices and related products that are used to collect,separate, manufacture and process various components of blood and cells.With our innovative technologies and service offerings, we touch apatient's life every second of every day and are committed to continuing toincrease the number of patients we serve.With some of the best and brightest minds in the industry, an unmatchedglobal footprint, comprehensive benefits and a distinct culture, TerumoBlood and Cell Technologies is a great place to work, grow and be part of ateam that is focused on making a difference. Consider joining our team andunlock your potential.This position represents the quality organization as an integral team memberon development projects for medical devices, and supports continuousimprovement efforts within the Design and Development process. The DesignQuality Engineer (QE) supports release of world class quality products byensuring rigorous execution of the design and development activities andcompliance to the QMS procedures. Ownership includes critical deliverables ofthe development process including Risk Management evidence, Test MethodValidation activities, Statistical Analysis/Method support, and DesignVerification planning/execution. They ensure adherence to customer andregulatory requirements are demonstrated and help to ensure successfultransfer of the design to manufacturing.ESSENTIAL DUTIESWorks in a cross-functional, collaborative, team-based environment;collaborating closely with IandD project leads and teams to bring products tomarEnsures compliance to design and develoment QMS procedures,Facilitates and supports risk management activities including Hazard Analysisand FMEAStatsResponsible for Test Method Validation activities to support DesignVerification ExecutionalAssists and may lead Design Verification planning and protocol developmentContributes to the development and refinement of Design Control policies andprocedures to ensure they comply with appropriate standards, regulations,and industry best practiceAnticipates roadblocks, provide direction for navigating the quality systemand supporting applications.Takes an active role in Design Reviews to assess quality of the design,design for reliability, manufacturing, and servicing.Responsible for accurate, independent evaluation of Design History Filedocumentation and overall compliance to the Quality System.Guides the successful completion of major programs and may function in aproject leadership role. Erroneous decisions or recommendations wouldtypically result in failure to achieve major organizational objectives.Directs one or more major phases of complex engineering work, utilizingengineering skills to devise entirely new approaches to problems encounteredin projects.Develops new processes that have a significant impact on multiple disciplines.Contributes to the establishment of business objectives, goals, budgetsand costs as requested.Presents complex technical information/analysis, and responds to questionsfrom technical staff members and management regularly and effectively.Mentors less experienced engineers.Provides broad-based direction for subordinates and colleagues withinfunctional area and cross functionally.Applies technical expertise to complex tasks with in-depth knowledge ofrelated work areas.Employs in-depth knowledge of cross functional and related technical areas,applying knowledge to other areas.Displays accessibility and sought out for consultation on a broad range ofcomplex technical and industry issues engineering staff and management.Works on complex issues where analysis requires an in-depth evaluation ofvariable factor

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