.Descripción y detalle de las actividadesPosition SummaryThe primary function of this job is to improve Operations/Manufacturing systems in the plant for error proofing and process controls for New Automated Equipment/Processes and existing production automated equipment or systems. Create standard systems as a guideline to make improvements in cost, quality and delivery of devices, and develop design standards for new automated systems modeling DfX tools for implementation into manufacturing. This position will provide technical and managerial leadership in the operations facilities and core teams in identifying and implementing process improvements and automated systems and serve as SME for automation assembly processes.Essential Duties & ResponsibilitiesProvide support with system-level view of technical issues, options and recommendations.Train and implement projects using PFMEA, DFA / DFM and MSD process tools.Support and/or lead process validation per process master validation plans (IQ, Process Characterization, TMVs, OQ and PQ), manufacturing procedures, etc. Own CSV's or Computer System Assurance of equipment/software.Assure process controls are in place along with error proofing. Use knowledge of error proofing processes to reduce quality incidents.Work with Operations and R&D Core teams to assure implementation of new designs, core processes and declarations.Provide expertise with structured problem-solving tools (i.E. Black Belt, Shainin Tools) with the supporting Operations organizations.Develop automation requirements supporting production lean initiatives and provide automation building block roadmap for production implementation.Work with Operations/facilities and site Management on proper execution of PM processes.Create and implement cost savings ideas and recommendations.Act as technical lead to Operations, Supplier Quality and the Supply Chain by interpreting processes involved with assembly and production techniques providing the best value versus cost.Experiencia y requisitosKnowledge & SkillsProven track record of excellent technical and problem-solving techniques.Experience with structured problem-solving techniques & root cause analysis.Experience with Minitab, or other statistical applications.Must have a successful track record of implementing new designs and/or significant design changes. This includes active participation in the entire process of design, test, manufacturing start-up, and launch of projects.Ability to leverage and/or engage others to accomplish projects.Good verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and respects deadlines. Good organizational and follow-up skills, as well as attention to detail.Process Validations Knowledge.Good planning skills.Minimum Qualifications, Education & ExperienceMust be at least 18 years of age
