The Research & Development (R&D) Manager is responsible for leading the strategy, development, and successful launch of new products and line extensions within the medical device industry. This role ensures alignment with business objectives, regulatory requirements, project timelines, and market needs while driving innovation, technical excellence, and cross‑functional collaboration. Lead the end‑to‑end execution of new product development programs and line extensions, ensuring alignment with business objectives, timelines, and regulatory requirements. Translate customer, clinical, and market insights into clear engineering requirements, product specifications, and innovative design solutions. Own Design Control activities in compliance with applicable regulatory standards (e.g., FDA, ISO), including design inputs, outputs, verification, validation, and design reviews. Ensure disciplined project progression through established stage‑gate processes, maintaining high‑quality deliverables and documentation at every phase. Collaborate closely with Marketing and Clinical teams to ensure product concepts and designs align with user needs, clinical outcomes, and market expectations. Partner with Sustaining Engineering, Manufacturing, and Operations teams to incorporate Design for Manufacturability (DFM), scalability, and cost‑efficiency into product development. Proactively identify, assess, and mitigate technical risks while defining and executing robust testing strategies to ensure product performance, safety, and reliability. Oversee prototyping, testing, and iterative design cycles, enabling rapid learning while maintaining design integrity and regulatory compliance. Lead design transfer activities to manufacturing, ensuring readiness through proper documentation, process validation, and cross‑functional alignment. Provide clear and consistent communication regarding project status, milestones, risks, and mitigation plans to stakeholders and senior leadership. Minimum of 7+ years of Research & Development experience within the medical device industry. Minimum of 3+ years of leadership experience managing technical teams or product development organizations. Proven experience leading and managing multiple product development programs simultaneously. Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical field required. Master’s Degree (MBA, Engineering, or related discipline) preferred. Advanced English proficiency required. #J-18808-Ljbffr