Atuo como especialista em projetos de dispositivos médicos regulamentados pela ANVISA. Elaboração de documentos conforme requisitos da RDC 665, ISO 13485, ISO 14971, IEC 62366, IEC 60601

working toward technical standards drafting and revising standards

Participation in the development of standards

I work with technical documentation involving medical device projects, meeting the requirements of RDC 665 and the requirements of ISO 13485.

Teacher for engineering courses. I taught basic mathematics classes, calculus I, calculus III, mathematical methods, electrical projects, workplace safety, product development, process monitoring.

Technical writing of documents related to medical device projects, meeting current regulatory requirements (RDC 665 and ISO 13485). Document review control, as well as control and updating procedures for creating new documents to meet new requirements. Audited directly by risk management in accordance with ISO 14971 requirements.

Technical writing of documents related to medical device projects, meeting current regulatory requirements (RDC 665 and ISO 13485).

Technical writing of documents related to medical device projects, meeting current regulatory requirements (RDC 665 and ISO 13485).

Was expected from me to control and manage quality events related to the area, support problems and questions from the local and global factory, and support the 16 product engineers in the tracked tractor area.As an additional contribution, I participated in cost reduction projects, carried out the evaluation and release of more than 800 technical changes, and had an active participation in the insertion of 2 new machines in the production line in order to minimize the rework generated by… Show more Was expected from me to control and manage quality events related to the area, support problems and questions from the local and global factory, and support the 16 product engineers in the tracked tractor area.As an additional contribution, I participated in cost reduction projects, carried out the evaluation and release of more than 800 technical changes, and had an active participation in the insertion of 2 new machines in the production line in order to minimize the rework generated by this process. Show less