Design and Development (D&D) Analyst - São José do Rio Preto - SP

The Design and Development Analyst is an experienced professional who plays an essential role in the advanced

development of medical devices, with a focus on innovative solutions that provide significant improvements in

patients' quality of life. He/she is responsible for leading critical parts of the design and development process,

ensuring that devices meet functional, regulatory and clinical requirements, as well as contributing to the

optimization of manufacturing and compliance processes.

• Coordinating the development of complex medical devices, ensuring the integration of clinical and user
• requirements.
• Define and validate the selection of biocompatible materials and manufacturing processes, in
• accordance with ISO 10993 and ISO 13485.
• Developing and reviewing validation and verification test protocols, ensuring compliance with
• standards such as ISO 5840.
• Prepare and review technical and regulatory documentation, ensuring compliance with international
• standards, including FDA 21 CFR Part 820 and MDR.
• Participate in and lead project and design reviews, ensuring product compliance with technical and
• clinical specifications.
• Manage post-launch changes, ensuring documentation and continuity of compliance according to ISO
• 13485.