Design Assurance Engineer 2 CR Alajuela, Costa Rica + **Education / Educación:** Bachelor’s degree in life sciences, engineering, or related discipline. + **Experience / Experiencia:** 2-year experience minimum as a technical field professional and in similar positions. + **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):** Knowledge on the applicable standards-regulations, such as, QSR, MDR, MDSAP, ISO13485, ISO14971 + **Languages** **​​** **required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):** The candidate must be fluent in English, written and verbal. + **Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:** Microsoft Office Tools. + **Qualifications / Cualificaciones:** + Influencing skills. + Drive for results + Peer relations + Decision quality + Problem solving + Planning + Informing + **Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:** Role: + Provide support to Costa Rica manufacturing site, on market medical devices and their contract manufacturers. + Facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts. Duties & Responsibilities: + Participate independently on sustaining product projects, assuring project is clearly defined and stays on track, confirming product inputs are continuing to be met, and necessary verification, validation and risk management activities are completed. + Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal procedures/policies. + 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. + Assess change requests of product for impact to design, determine supporting information required for implementation of changes. + Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility and conformance to product requirements. + Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable local and international standards. + Ensure successful transfer of new products to production facility. + Review production processes for quality of verification and validation methods when a design change was performed to the existing products at the Facility. + Review and approve verification and validation test plans at the design stage. Ensure verification results demonstrate compliance to medical device standards. + Lead project teams with verification/validation statistical methods and design controls. Resources administration: + Innovate processes to improve efficiency and ensure compliance. + Implementation of cost reduction projects that support business strategies. + Maintain, improve and simplify procedures, processes and methods. + Personnel administration + Support and promote the implementation of EHS programs to ensure people safety and environment health. + Promote development of talented people and collaborators’ engagement, through the execution of 1:1, open sessions, merit recognition, people motivation, effective hearing, assertive communication, feedback provision, appropriate environment, leadership. + Ensure adequacy of the Regulatory training matrices and verify that personnel is properly trained on time. Verify activities are executed in accordance with procedures and regulations. + Develop, lead and facilitate to the direct reports all the required tools, methodologies and materials to ensure the successful execution and completion of the organizational and individual objectives and operational excellence. + Promote creation and execution of Individual Development Plans (PDI) from direct reports. + Record and communicate to management performance issues, disciplinary actions, performance evaluation in accordance with a world class company. + Provide performance reports to the personnel as per the guidance provided by Human Resources. Feedback to improve performance should be provided to the personnel as required.