Education / Educación: Bachelor's degree life sciences, engineering or related discipline.Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device DirectiveLanguages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Advanced english Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Microsoft OfficeQualifications / Cualificaciones: • Priority Setting• Customer Focus• Drive for Results• Planning• InformingSummary of Duties and Responsibilities / Resumen de funciones y responsabilidades:• Provide design assurance support for on market medical devices.
This role will be responsible to facilitate the application of design controls while supporting manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.• Duties are listed in order of greatest importance.
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.• Participate on sustaining product projects with support of lead/manager, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
