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Acara Solutions E4 - Design Quality Engineer in Lakewood, Colorado

Acara Solutions is assisting our client in Denver Colorado to fill a criticalrole within their Design Quality Team. This is a Direct Hire role withexcellent compensation and benefits. Candidates must be a US Person or GreenCard Holder to be considered.The Design Quality Engineer (QE) supports release of world class qualityproducts by ensuring rigorous execution of the design and developmentactivities and compliance to the QMS procedures. Ownership includes criticaldeliverables of the development process including Risk Management evidence,Test Method Validation activities, Statistical Analysis/Method support,and Design Verification planning/execution. They ensure adherence tocustomer and regulatory requirements are demonstrated and help to ensuresuccessful transfer 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 development 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 factors. Exercises judgment in selecting methods, techniques andevaluation criteria for obtaining results.Keeps updated on recent technical advances within the industry and appliesthis knowledge to products and processes.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.May contribute to the establishment of business objectives, goals, budgetsand costs.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's of Science degree or Master of Science degree in Engineeringpreferred.Bachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.ExperienceMinimum 8 years experience.Two years of GMP manufacturing experience required.SkillsRequires demonstrated skills in Test Method