Overview / Descrição
The Product Owner is responsible for planning, coordinating, and supervising all activities related to the complete life cycle of medical devices, acting as a central point of integration between Engineering, Quality, Clinical, and Regulatory, ensuring efficient execution, traceability, and compliance with Quality Management System requirements.
O Product Owner é responsável por planejar, coordenar e supervisionar todas as atividades relacionadas ao ciclo de vida completo de dispositivos médicos, atuando como ponto central de integração entre Engenharia, Qualidade, Clínica e Regulatório, garantindo execução eficiente, rastreabilidade e conformidade com os requisitos do Sistema de Gestão da Qualidade.
Product Lifecycle Management e Design Controls
Manage all phases of the medical device lifecycle, including User Needs, Design Inputs, Design Outputs, Design Verification, Design Validation, transfer to production, and post-launch maintenance.
Ensure complete traceability between requirements, development activities, testing, changes, and documentary evidence.
Ensure that all activities comply with Design Controls requirements, as per ISO 13485 and CFR 21.
Agile Project Management and Sprints
Plan, organize, and manage development sprints, typically lasting two weeks.
Work closely with R&D engineers, Product Management, and Directors to define scope, objectives, and estimates.
Manage backlogs, sprint boards, and schedules in tools such as ClickUp or equivalents.
Ensure the execution of development activities in accordance with the technical and regulatory milestones of the project.
Verification & Validation Management
Plan, track, and monitor Design Verification and Design Validation activities.
Coordinate the interface between Engineering, Quality, Clinical, and external laboratories.
Ensure that protocols, test reports, and associated records are complete, reviewed, approved, and properly filed.
Monitor risks, delays, and dependencies that may impact verification and validation schedules.
Task and Documentation Logging
Convert technical discussions, decisions, and strategic alignments into structured tasks with defined responsibilities and deadlines.
Ensure that all product-related activities are logged, updated, and traceable.
Document suspended, canceled, or reprioritized tasks, ensuring resumption without loss of context.
Maintain a complete and auditable history of development, testing, changes, and technical decisions.
Multifunctional Communication and Coordination
Participate in regular meetings with the Head of PMD, Directors, and other stakeholders.
Provide progress updates, highlight risks, and escalate impediments in advance.
Act as a focal point between local and global teams, ensuring continuous alignment.
Facilitate communication between Products & Features, Engineering, Quality, Clinical, and Regulatory throughout the product lifecycle.
Problem Solving, Risk Management, and Prioritization
Monitor technical, regulatory, operational, or material-related issues that may impact the product.
Adjust priorities as project needs change, ensuring document integrity and traceability.
Support impact analyses of product changes throughout the lifecycle.
Collaborate with global teams to maintain alignment with product timelines and strategies.
Requisitos / Requirements
Bachelor's degree in Engineering, Health Sciences, Business Administration, Technology, or related fields.
Minimum of 2 years of experience in project management, product ownership, or equivalent roles in regulated environments.
Practical experience in the development of medical devices or regulated products.
Proven experience with Design Controls, including User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.
Requisitos desejáveis / Desirable requirements
Postgraduate degree or specialization in project management, products, quality, or regulatory areas.
Experience with ISO 13485, 21 CFR 820 (FDA), ANVISA, MDR EU, among others in the field
Experience in agile methodologies (Scrum, Kanban) applied to hardware or medical device development.
Experience interacting with global teams and external suppliers.
Office Suite: Basis for structuring, controlling, prioritizing, and monitoring complex activities, schedules, indicators, traceability, and operational and regulatory reports.
Project Management: Essential for organizing, prioritizing, monitoring, and tracking deliveries, integrating multiple areas, deadlines and dependencies—compatible with tools such as ClickUp, Jira, or similar.
Regulatory Documentation Management: Essential for preparing, reviewing, maintaining, and controlling technical and regulatory documentation, ensuring compliance, versioning, and traceability in regulated environments.
Document Organization: Complements regulatory management by ensuring structure, standardization, control, and easy access to critical information, including in electronic document management systems (EDMS).
Advanced English: Indispensable for reading, writing, comprehension, and conversation, especially for interacting with technical documents, international standards, audits, and global stakeholders.
Graduação completa em Engenharia, Ciências da Saúde, Administração, Tecnologia ou áreas correlatas.
Experiência mínima de 2 anos em gerenciamento de projetos, product ownership ou funções equivalentes em ambientes regulados.
Experiência prática em desenvolvimento de dispositivos médicos ou produtos regulados.
Vivência comprovada com Controles de Projeto (Design Control), incluindo User Needs, Design Inputs, Design Outputs, Design Verification e Design Validation.
Requisitos desejáveis:
• Pós-graduação ou especialização em gestão de projetos, produtos, qualidade ou áreas regulatórias.
• Experiência com ISO 13485, 21 CFR 820 (FDA), ANVISA, MDR EU, entre outros da área
• Experiência em metodologias ágeis (Scrum, Kanban) aplicadas ao desenvolvimento de hardware ou dispositivos médicos.
• Experiência em interação com equipes globais e fornecedores externos.
• Pacote Office: Base para estruturação, controle, pri...
Note: Este texto preserva o conteúdo original, removendo formatação invasiva e consolidando a estrutura para maior clareza, mantendo a linguagem original.
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