Engineer II, QualityLocation: OnsiteStatus Type: Full TimeQualificationsRequired:Bachelor's Degree in Engineering disciplineA minimum of 2 years of device/combo product design and development experience, working in a highly regulated environment, quality, manufacturing, or engineeringMaster's Degree considered as an additional 2 years of experiencePreferred:ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certificationsQuality Engineering ExperienceSkills & CompetenciesBasic knowledge of Risk Management, device manufacturing, and statistical analysis techniques including use of Minitab (or comparable) softwarePossess a good balance of basic technical expertise, analytical thinking, and communication skills for resolving issues internal and external to the organizationComfortability in speaking with external partners regarding business needCompetent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)Strong time management skillsWork to acquire and develop new skillsAbility to apply competency in difficult situationsEngages colleagues with the Enable Values in mindAbility to follow defined procedures and proactively diagnoseAbility to collaborate and maintain cooperative work relationships with othersAbility to adapt to change and handle unexpected situations, Requires occasional guidanceAbility to maintain a positive attitude, show empathy for others, and always do the right thingAbility to have a positive impact on others in support of company goals and a healthy work environmentAbility to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidanceShows inquisitiveness about how situations are evolving and identifies how to adapt early to changing situationsPhysical RequirementsMust be able to gown and work within a clean room and/or lab environment.Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.Position requires being physically present on the premises during regular company hours or as approved by managementResponsibilitiesSupport Senior Engineers with any platform and partner needsEnsure product quality targets are achieved by supporting the design and implementation of test plansProvide the design team with statistical guidance including sample size selection, test method validation strategies, and defining evidential requirements to support risk-management claims and mitigationsGuide the identification and traceability of requirements from Feasibility through Design Release. Ensure platform requirements are defined, verifiable, and are not redundantSponsor a robust execution of Risk Management activities throughout all phases of development and assurance the identified risks have been reduced as far as possibleEnsure that requirements are appropriately defined and tested and that the stress-conditions appropriately challenge the design to insure regulatory and pharma-partner needs are satisfied by the assigned subsystemsGuide various process and product development activities through sample-size determination, distribution identification and data analysis; and other means such as the selection, support and appraisal of inspection plans and process controlsProvide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action programIncorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platformProactively communicate project risks and status to management and external partners as neededManage other job functions and duties; and provide for other product development projects, teams and activities as requiredProvides project status to leadershipNearest Major Market: Cincinnati#J-18808-Ljbffr