• Responsible of the sustaining of 5 production lines.• Responsible of communicating status of sustaining activities and projects to the customers. Support on experiments requested by the customers.• Responsible of managing resources according to the priorities established by the customers and program manager.• Validation of manufacturing processes, components, packaging and equipment (Engineering Studies, IQs, OQs, PQs, FAIs).• Design and implementation of fixtures for the… Show more • Responsible of the sustaining of 5 production lines.• Responsible of communicating status of sustaining activities and projects to the customers. Support on experiments requested by the customers.• Responsible of managing resources according to the priorities established by the customers and program manager.• Validation of manufacturing processes, components, packaging and equipment (Engineering Studies, IQs, OQs, PQs, FAIs).• Design and implementation of fixtures for the manufacturing processes.• Creation and revision of Manufacturing and Quality Documentation (WIs, DHRs, BOMs, Specs, Drawings, Master labels).• Responsible of Root Cause Analysis for CAPAs, Complaints and NCMRs; determine corrective and preventive actions.• Scrap analysis and reduction of top offenders.• Work as a couch for the Engineering Technicians and Engineering Interns.• Present Project Dashboards and Engineering Metrics to the upper management in our Key Process Indicators meeting.• Responsible of the introduction of new products, coordinating all the activities of a multifunctional team in order to accomplish the milestones within the planed dates.• Continuous communication with the customer and fast response to the new requirements according to the scope changes. Show less

• Responsible of the sustaining of 7 production lines (sewing process).• Changes to Manufacturing Documents such as: Device History Records, Standard Operating Procedures, Process Instructions, Spec Boards, Work Instructions and Visual Aids.• CAPAs/Complaints/NCMRs investigations leader and team member.• Scrap analysis and reduction of top offenders.

• Leader of Quality Systems Lean projects using DMAIC methodology.• Personnel training in the different behaviors of the Enterprise Operating System.• Personnel preparation for audits (entire Facility).• FDA, COFEPRIS, TUV, NSAI, DEKRA and internal audits participation (back room, front room, Subject Matter Expert).• Customer Complaints Handling and Investigation.• Direct contact between Medtronic México and Product Experience Management and Post Market Product Assurance… Show more • Leader of Quality Systems Lean projects using DMAIC methodology.• Personnel training in the different behaviors of the Enterprise Operating System.• Personnel preparation for audits (entire Facility).• FDA, COFEPRIS, TUV, NSAI, DEKRA and internal audits participation (back room, front room, Subject Matter Expert).• Customer Complaints Handling and Investigation.• Direct contact between Medtronic México and Product Experience Management and Post Market Product Assurance departments for all products manufactured at Medtronic Tijuana Facility.• Improvement on compliance metrics (entire facility): Investigations/Actions On Time Closure. Show less

• Provide support to the R&D Department (endovascular products).• Software development in order to trace and manage work orders for six projects. The application involves Production, Quality, Washing and Shipping departments.• Software development for kitting area: label printing automation, bar codes scanning and capturing automation.• Documentation for the introduction of new products: Change Orders, Process Instructions.• Support on the introduction of new products: Timing;… Show more • Provide support to the R&D Department (endovascular products).• Software development in order to trace and manage work orders for six projects. The application involves Production, Quality, Washing and Shipping departments.• Software development for kitting area: label printing automation, bar codes scanning and capturing automation.• Documentation for the introduction of new products: Change Orders, Process Instructions.• Support on the introduction of new products: Timing; tools, mandrels and fixtures designs (solidworks)• Production lines support; provide feedback to design site regarding the quality of the product and materials; perform and send reports to design site including material/time costs, improvements to the design and manufacturing process. Show less