Deep knowledge applied in the design control of medical devicesActing as a project manager on the development of lung ventilatorsManaging a team of specialists that include mechanical, electronic and software engineersLeading the team on the implementation of a usability engineer process in the product development life-cycleResponsible to guarantee that all engineering and design controls requirements are met for INMETRO and CE certification Leading the team on the adequacy… Show more Deep knowledge applied in the design control of medical devicesActing as a project manager on the development of lung ventilatorsManaging a team of specialists that include mechanical, electronic and software engineersLeading the team on the implementation of a usability engineer process in the product development life-cycleResponsible to guarantee that all engineering and design controls requirements are met for INMETRO and CE certification Leading the team on the adequacy of design documentation and preparation of the premarket notification to FDA – 510(k)Close contact to laboratories and notify bodies to support product certification Responsible for the implementation and maintenance of the risk management process according to ISO 14971Team and department performance managementDevelopment and accountability of R&D projects in return to federal tax incentives received through the "Lei da informática"Knowledge on software development processes for medical devices Show less

Acting as a project manager in performance improvement and cost reduction projects in medical devices. Team management.Development of project management plans.Creation of project status reports, action plans and risk management reports.Support in the definition of the technology roadmap.Elaboration of technical documentation including costumer requirement specifications, product specifications, risk analysis, DFMEA, verification and validation procedures.Design of… Show more Acting as a project manager in performance improvement and cost reduction projects in medical devices. Team management.Development of project management plans.Creation of project status reports, action plans and risk management reports.Support in the definition of the technology roadmap.Elaboration of technical documentation including costumer requirement specifications, product specifications, risk analysis, DFMEA, verification and validation procedures.Design of mechanical and pneumatic systems in anesthesia machines, including anesthetic gas blenders (FGF system), drive gas manifolds, anesthetic breathing systems, gas inlet manifolds, gas scavenging systems and cabinets.Follow-up of third part laboratory certification and product validation in the field.Follow-up of project transfer phase to productionFollow-up of customers complaints during product lifecycle.Support to technical assistance team through training, seminars, elaboration of service manuals and technical analysis.Member of an internal team responsible for the creation of the design controls and design change procedures, aligned to PMBOK practices, FDA guidance and Philips internal policies. Show less

Project management of a new model of anesthesia machine.Management of performance improvement projects.Development and improvement of pneumatic sistems and components applied in medical devices as lung ventilators, anesthesia machines, anesthetic breathing systems and oxigen therapy devices.Elaboration of production technical documents (Assembly procedures, verification procedures, packaging procedures, etc)Company representative person in medical standard revision meetings at… Show more Project management of a new model of anesthesia machine.Management of performance improvement projects.Development and improvement of pneumatic sistems and components applied in medical devices as lung ventilators, anesthesia machines, anesthetic breathing systems and oxigen therapy devices.Elaboration of production technical documents (Assembly procedures, verification procedures, packaging procedures, etc)Company representative person in medical standard revision meetings at ABNT (Brazilian Technical Standard Association) Show less

Elaboration of technical documentation (DFMEA, PFMEA, Process flow chart, Folhas de método, etc.)Follow-up of process try-outs of mold injected, stamped and machined partsProcess time studyDesign of control devices, test devices and Poka-yokes.

Internal Quality AuditorElaboration and control of quality management documents and records.Elaboration of process and incoming inspection plansEvaluation and selection of suppliersElaboration of Quality KPI's Control of measuring and monitoring devicesControl of non-conforming product, corretive and preventive action.