The R&D Manager will lead the research and development efforts in the design, testing, and commercialization of innovative spinal medical devices. The ideal candidate will manage a team of engineers while collaborating closely with cross-functional departments to drive projects from concept through regulatory approval and into commercialization.

Key Responsibilities:

• Lead and manage R&D teams, providing technical and strategic direction for spinal device projects.
• Oversee the planning, execution, and completion of R&D projects, ensuring timelines, budgets, and quality standards are met.
• Mentor and develop team members, fostering a culture of innovation, collaboration, and continuous improvement.
• Drive the development of new spinal products and enhancements to existing product lines from concept through commercialization.
• Ensure that R&D projects comply with regulatory standards (FDA, ISO, etc.) and quality assurance requirements.
• Collaborate with cross-functional teams including regulatory, quality, clinical, and marketing to support product launches.
• Identify market needs and trends within the spinal device sector and drive innovation to meet those needs.
• Develop and execute the R&D strategy in alignment with company goals, focusing on cutting-edge technologies and materials.
• Explore new research methodologies, materials, and processes to stay ahead of technological advancements.
• Ensure all R&D activities comply with local and international medical device regulations.
• Partner with regulatory and quality teams to prepare technical documentation for regulatory submissions (FDA, CE, etc.).
• Collaborate with external partners, suppliers, and consultants to support product development initiatives.
• Communicate project progress, risks, and outcomes to senior management and stakeholders regularly.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (Master’s or PhD preferred).
• 7+ years of experience in medical device R&D, with at least 1 year in a leadership or management role.
• Proven experience in the development of spinal or orthopedic medical devices is highly desirable.
• Experience with product development processes, design controls, and risk management practices in the medical device industry.
• Familiarity with regulatory requirements (FDA 510(k), PMA, CE marking, ISO 13485, etc.).
• Proficiency in CAD software (SolidWorks or similar) and FEA tools.