Chihuahua, Mexico
Ingeniero Biomédico con experiencia en ingeniería de manufactura y calidad de cliente siendo parte de la industria de dispositivos médicos. Interesada en proyectos relacionados a Introducción de nuevos productos, Investigación y desarrollo o Gestión del ciclo de vida del producto.
Manage Documentation requirements for new site Provide manufacturing assessment and alignment between multifunctional groups of the company Teach new team members on the databases, procedures and platforms of the company
Provide resolution of issues in process, method or documentation escalated by External Manufacturers or new JnJ sites as part of the transfer process. • Coordinate and document alignment of conclusions with functional teams: Research and Development, QA Make, QA Franchise, Process Engineering, Production, Training, QA Operations, Packaging, Planning and applicable groups. • Implementation of process improvement or remediation to expedite on time deliverables required by EM or new site. Acquisition, validation, drawings creation, Documentation updates, training (Drawings, D-Spec, eBOM, PFMEA, Process Instructions) • Participation in meetings to represent multifunctional group that aligned conclusion of findings, resolution, escalating impact of critical activities or risk on timeline. • Leader of projects: Coordinate, solve questions and monitor activities (investigation/change owner) of engineers (located in Mexico, USA and India) assigned to activities related to specific family of products. • Support to the team and other teams on IT questions (Windchill, JnJ platforms, software) • Implementation of tools to show information summary to high level (dashboard, trackers, projection using PowerBI, Project and Excel) • Train new engineers in the project on the governance and required activities.
Complaints owner for Class III medical devices. • Reportability handling with Medical Devices Regulation teams (all countries). • Communication with customer and related departments (Manufacture and Business Quality, Laboratory of Product Analysis, Clinician, Legal, Medical Safety Officer, Shipment and Delivery, Warranty, Intake) • ECM (Reports, email, Dashboards) • Data analysis to evaluate team results. Process improvement initiatives.
Biosense Webster Inc. -Smart space project, reconfiguration of production area: MLA owner, Equipment validation. -Design a flexible line to run three legacy products: Process analysis, New layout alternatives, validation summary of current active equipment. Equipment validation. -Capacity increase of production line: Process and equipment validation. New Layout proposal with lean department and its implementation. Cerenovus -Support on CAPA validation activities due to remediation after transference of new product from RnD to production environment, Pull test TMV and OQ for plastic injection molding machine, PQ of entire manufacturing process due to new molding parameters and quality operations added along the entire line. -Validation of equipment and process, adding experience of: IQF, PVE; CSV-E for custom winding equipment; COs procedure. Release of equipment drawing to production level. Participation in activities to attend quality observation for packaging process. -Validation procedures training for operations technicians and validation engineers. -Translate supplier documentation of custom designed equipment. -Implementation of new InfinityQS project as part of CAPA.
•Revisión, desarrollo y ejecución de entregables de validación. Adquisición, IQ, OQ, PQ y validación de software de equipos de manufactura y control de calidad de dispositivo médico. Soporte en: PPQ, DOE, revisiones de dibujos, traducción de instrucciones de trabajo, caracterización. •Evaluación de riesgos, planteamiento de requisitos, nivel de riesgo asociado y pruebas resultantes (validación) para equipos de acuerdo con GMPs •Validación del software de acuerdo con los requisitos reglamentarios, especialmente los requisitos especificados en regulaciones de dispositivos médicos, 21 CFR Part 820, 21 CFR Part 11 e ISO 13485. •Gestión del sistema de mantenimiento CMMS MAXIMO para Ciudad Juárez en relación con las tareas de mantenimiento preventivo y calibración. •Curso Orange Belt en metodología de manufactura esbelta 2019
En Departamento de Ingeniería Eléctrica y Computación Con M. en C. Ana Luz Portillo Hernández Coordinadora del Programa de Ingeniería Biomédica Apoyo al docente durante el periodo de acreditación del programa de ingeniería biomédica por CACEI. Asesoría de alumnos de la materia de Bioquímica, Fisiología, Anatomía, Química orgánica
Mtra. Victoria González Demoss Coordinadora de la Maestría en Cómputo Aplicado Asesoría de alumnos y apoyo en proyectos finales de la materia de Circuitos digitales, Cálculo, Ecuaciones diferenciales, Química Apoyo en plataforma Campus virtual, participante de CAMPUS PARTY 2017.