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Terumo BCT Engineer 3 - Design Quality in Lakewood, Colorado

Engineer 3 - Design Quality Please wait...Date: Nov 6, 2020Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 26761At 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.Work requires originality and judgment in the independent evaluation,selection, and substantial adaptation and modification of standardtechniques, procedures, and criteria. Performs work which requires abroad knowledge of precedents in the specialty area and a good knowledge ofprinciples and practices of related specialties. Duties are assigned toprovide experience and familiarization with engineering methods, independentthinking, and company practices and policies.This position represents the quality organization as a team member ondevelopment projects. The Design Quality Engineer (QE) ensures compliancewith QMS and design controls process and procedures. Ensure adheance tocustomer and regulatory requirements to help ensure successful transfer of thedesign to manufacturing.ESSENTIAL DUTIESEnsures compliance to QMS and design controls processes and proceduresFacilitate and support risk mangement activites. Highlights risks andunderstands how to approach and complete tasks, avoiding serious delays andconsiderable expenditure of time and resources.Contribute to the development and refinement of Design Controls policies andprocedures to ensure the comply with appropriate standards, regulations andindustry best practiceWork in a cross-functional, collaborative, team-based environmentAnticipate roadblocks, provide direction for navigating the quality systemTake an active role in Design Reviews to assess quality and complianceResponsible for accurate, independent evaluation of Design History Filedocumentation and overall compliance to the Quality System, Performindependent evaluation, selection, and application in making adaptationsand modifications to projectsReceives assigned total project leadership responsibilities on a portion ofmajor significant projects and will be given total management responsibilityfor smaller projects.Manages and provides leadership for the functional group's development,direction, and effectiveness, adhering to organizational policies andprocesses and supporting overall business and corporate objectives.Implements and understands FDA or regulatory requirements as necessary.Applies technology principles to multiple tasks. Working knowledge ofcross-functional and related technical areas.Advises team members pro-actively on technical ideas and promotes skilldevelopment of team work.Interacts with peers across projects to secure resources and commitments.Follows technical specification requirements and provides feedback on varioustechnical processes and procedures.Presents effectively complex technical information/analysis, and respondsto questions from technical staff members and management.OTHER DUTIES AND RESPONSIBILITIESWork direction responsibility may include technicians and junior engineers.May work with manufacturing and other functional groups on manufacturing andregulatory compliance issues.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the