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

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • Modalidade: Presencial Descrição: 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.
  • Requisitos: Education and work experience requirements: Minimum requirements: Degree in Engineering, Product Design, Biomedicine or related field in exact or biological sciences.
  • Desirable requirements: Postgraduate degree or MBA in related areas would be a plus.
  • Experience: Minimum 2 years in D&D, Quality, preferably in the medical devices sector or other regulated sectors.
  • Personal attributes: Strategic thinking and complex problem solving.
  • Ability to work in a multidisciplinary team.
  • Proactivity and autonomy in decision-making.
  • Organizational and time management skills.
  • Professional skills: Required: Proficiency in Office Package (Windows) and project management tools; Advanced English for reading and writing, intermediate for speaking; Preparation of Technical and Regulatory Reports; Knowledge of product development in compliance with regulations.
  • Desirable: Intermediate knowledge of medical device industry regulations (ISO 13485, FDA 21 CFR Part 820, MDR, ANVISA, etc.
  • ); Intermediate knowledge of ISO 10993 and 5840 standards; Experience with CAD (Computer-Aided Design) tools; Familiarity with change management in projects and quality control systems.

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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