.Descripción y detalle de las actividadesResponsible for investigational activities relating to infusion pumps and monitoring devices. This role manages a team of engineers and technicians and is responsible for the development, implementation, and maintenance of processes associated with complaint investigations requiring failure analysis of returned infusion systems and component parts from servicing operations. This individual will be responsible for the integrity of the investigations and ensure investigation conclusions are clear, supported, robust, and compliant. This individual will establish best practices in investigation failure analysis processes for large volumes of complaints and associated root cause determination, including inspection, test protocols and methodologies. - Develops, implements, and maintains complaint investigation failure analysis processes including writing requirements, process documentation, inspection and test protocols for systems, modules and component parts. -Design, purchase and release of investigation test fixtures for failure analysis lab. This may also include leading and performing IQ/OQ/PQ test fixture verification activities that business process deems necessary. -Ability to solve complex problems by developing investigation test methodologies, processes & training materials. -Serve as a Subject Matter Expert for failure analyses that includes both internal functional support and external customer support with respect to analysis findings and associated improvements initiatives. -Perform remediation of complaint process as part of on-going FDA compliance activities & 483 corrective actions. -Own and/or lead investigations & root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary. Support CAPA investigations by R&D and Operations where field return analyses may assist in those CAPA investigations. Support, and provide input to, monthly complaint trend reviews and resulting CAPA triggers. -Develop, compile and present complaint investigation and failure analysis summary metrics to Senior and Executive Management, as necessaryExperiência y requisitos- BS/BA in engineering discipline or equivalent experience with lab -Experience leading a Failure Investigation team -Professional certification is a plus; e.G. Six Sigma Green Belt, etc. -Minimum of 7 years of experience in failure analysis, manufacturing operations, servicing, and/or R&D activities leading investigation teams or designing inspections and tests for complex electro-mechanical equipment. -Demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices. -Must possess ability to establish new failure investigation processes, test protocols, and procedures and to build a team performing these activities