• Education / Educación: Bachelor degree, mastery desirable• Experience / Experiencia: Min 5 years' experience, preferably in medical device industry• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Experienced with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485 and Medical Devices Directive.Experienced with ISO 14971, Risk Management.Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.Working knowledge of requirements analysis, including development of testable and measurable specifications.Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.Preferred: Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment.• Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/ Fluent English• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Microsoft Office Tools Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:Essential 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:o Participate independently on new product development projects, assuring product inputs are clearly identified and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.
Test method validation would be an element of assuring verification/validation is acceptable.o Participate independently on sustaining product projects, 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.o Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.o Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.o Assess change requests of product for impact to design, determine supporting information required for implementation of changes.• Qualifications / Cualificaciones: o Drive for resultso Peer relationso Decision qualityo Problem solvingo Planningo Informing