Coordenador de Laboratório

Horário: De segunda à sexta, das 8h às 17h 48min com 1h de almoço. Modalidade: Presencial Descrição The Laboratory Coordinator is responsible for planning, organizing, and supervising all activities of the characterization and testing laboratory, ensuring the execution of tests with high technical reliability and full compliance with the requirements of the Quality Management System (QMS) and international regulatory standards, such as ISO 13485, FDA 21 CFR Part 11/820, MDR, and ANVISA. This role acts strategically in the planning and execution of Verification & Validation (V&V) studies, in the development and validation of test methods, in the management of equipment and samples, and in the integration with PMO, Engineering, Manufacturing, Quality, and Regulatory Affairs, ensuring that the data generated support critical decisions in the new product development cycle. 1. Strategic Planning and Coordination Plan, prioritize, and coordinate laboratory activities, ensuring that demands are aligned with development and V&V schedules. Maintain and manage the testing schedule with the PMO, ensuring integration between the project plan and laboratory capacity. Actively participate in V&V planning with Engineering, Quality, and Regulatory teams, ensuring proper definition of scope, requirements, and acceptance criteria. 2. Test Method Development and Validation Develop, implement, and validate test methods for functional and mechanical characterization of prototypes and medical devices. Define critical parameters, technical specifications, and acceptance criteria based on international standards and regulatory requirements. Participate in technical reviews with Engineering and Quality to ensure robustness and reliability of the proposed methods. 3. Test Execution and Supervision Ensure the execution of advanced tests, including: Hydrodynamic testing of heart valves; Mechanical tests for tensile, compression, bending, torsion, and fatigue; Use simulation of delivery systems (catheters and applicators); Packaging resistance and integrity tests; Device durability and lifecycle tests; Dimensional characterization, friction forces, pressure, and flow. Critically analyze results, identify deviations, and coordinate failure investigations with the support of multidisciplinary teams. 4. Equipment and Infrastructure Management Ensure calibration, qualification, and validation of all equipment, maintaining validated status for regulated use. Supervise preventive and corrective maintenance routines, as well as periodic functional checks. Evaluate, specify, and implement new equipment and technologies, ensuring compatibility with standards and development needs. 5. Sample Management and Traceability Establish robust processes for organization, traceability, and controlled retention of samples, prototypes, and tested devices. Ensure proper storage, segregation, and disposal in accordance with internal procedures and regulatory requirements. Maintain an up-to-date and accessible inventory to support audits and investigations. 6. Documentation Development and Regulatory Support Draft, review, and approve SOPs, Work Instructions, protocols, and technical reports. Prepare and consolidate testing documentation for national and international regulatory submissions (FDA, MDR, ANVISA). Ensure reports are complete, consistent, and traceable to meet inspection and audit requirements. 7. Resource and Partnership Management Coordinate relationships with suppliers, external laboratories, and service providers, ensuring they operate under compatible quality standards. Ensure outsourced activities are aligned with internal regulatory and technical requirements. 8. Management of Equipment, Fixtures, and Infrastructure Ensure that all laboratory equipment, fixtures, holders, and measuring instruments are operational, validated, qualified, and calibrated according to the QMS and regulatory standards. Collaborate with the prototyping team on the development and validation of fixtures, holders, and testing accessories, ensuring accuracy and reliability of tests. Maintain the spare parts inventory and auxiliary resources to prevent interruptions in the testing schedule. Ensure traceability and control of all equipment and instruments, guaranteeing compliance and continuous availability to meet project and V&V demands. 9. Innovation, Continuous Improvement, and Technical Updates Research and implement new technologies, materials, and testing methods applicable to the development of heart valves and delivery systems. Stay updated on regulatory changes and technological advancements in the industry, acting as a technical reference for the team. Propose continuous improvements to increase efficiency, reduce risks, and enhance result reliability. 10. Regulatory Compliance and Audits Ensure all activities comply with ISO 13485, FDA 21 CFR Part 11/820, MDR, and ANVISA. Ensure complete, accurate, and real-time records, following Data Integrity principles and Good Documentation Practices. Support internal, client, and regulatory audits by providing robust and traceable evidence. Requisitos Minimum mandatory education Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, Production, or related fields), Biomedicine, Biotechnology, Physics, Chemistry, or equivalent programs with a compatible technical-scientific background. Desired education Postgraduate degree, MBA, or specialization in Biomedical Engineering, Laboratory Management, Quality, or Medical Device Product Development. Recommended courses and certifications Good Laboratory Practices (GLP); ISO/IEC 17025 – competence of testing and calibration laboratories; Good Manufacturing Practices (GMP); Training in test method validation and equipment qualification. Professional experience Minimum of 5 years of experience in testing laboratories or R&D, preferably in medical devices, with proven expertise in prototype characterization, functional and mechanical testing, and test method validation. At least 1 year in a coordination, technical leadership, or team supervision position in regulated environments. Knowledge of testing methodologies: Proficiency in physical and functional testing techniques applied in the laboratory, with the ability to critically analyze results. Reading and interpreting protocols: Ability to understand and validate technical and scientific documents, ensuring clarity and practical applicability. Laboratory data management: Knowledge of systems and tools for quality and secure control, traceability, and archiving of test data. Technical and regulatory standards: Familiarity with applicable legislation and standards (e.g., ISO 13485, GMP), ensuring adherence and compliance in laboratory processes. Technical communication: Ability to prepare clear and objective reports and communicate results effectively to the areas involved. Intermediate to advanced English: Ability to read and interpret technical documents, as well as written and verbal communication with international teams. Requisitos (Português) Formação mínima obrigatória Ensino superior completo em Engenharia (Mecânica, Biomédica, de Materiais, de Produção ou áreas correlatas), Biomedicina, Biotecnologia, Física, Química ou cursos equivalentes com base técnico-científica compatível. Formação desejável Pós-graduação, MBA ou especialização em Engenharia Biomédica, Gestão de Laboratórios, Qualidade ou Desenvolvimento de Produtos Médicos. Cursos e certificações recomendados Boas Práticas de Laboratório (BPL); ISO/IEC 17025 competência de laboratórios de ensaio e calibração; Boas Práticas de Fabricação (GMP); Treinamentos em validação de métodos de teste e qualificação de equipamentos. Experiência profissional Mínimo de 5 anos de atuação em laboratórios de testes ou P&D, preferencialmente em dispositivos médicos, com experiência comprovada em caracterização de protótipos, ensaios funcionais e mecânicos e validação de métodos de teste. Pelo menos 1 anos em posição de coordenação, liderança técnica ou supervisão de equipe em ambientes regulados. Conhecimento em metodologias de ensaio: Domínio de técnicas de testes físicos e funcionais aplicados em laboratório, com capacidade de análise crítica dos resultados. Leitura e interpretação de protocolos: Capacidade de compreender e validar documentos técnicos e científicos, assegurando clareza e aplicabilidade prática. Gestão de dados laboratoriais: Conhecimento em sistemas e ferramentas para controle, rastreabilidade e arquivamento de dados de teste com qualidade e segurança. Normas técnicas e regulatórias: Familiaridade com legislações e normas aplicáveis (ex: ISO 13485, BPF), garantindo aderência e compliance nos processos laboratoriais. Comunicação técnica: Habilidade para elaborar relatórios claros e objetivos e comunicar resultados de forma eficaz às áreas envolvidas. Inglês intermediário a avançado: Capacidade de leitura e interpretação de documentos técnicos, bem como de comunicação escrita e verbal com equipes internacionais. #J-18808-Ljbffr