Job Description: Director of Research and Development (Medical Devices)

Overview: We are currently seeking a highly skilled and experienced Director of Research and Development to head our R&D department, specializing in the innovation of advanced medical devices. The successful candidate will possess an extensive background in medical device engineering, a documented history of steering successful product development, and outstanding leadership abilities.

Key Responsibilities:

1. Strategic Leadership: Craft and implement R&D strategies that align with the broader company objectives, catalyzing innovation and nurturing a culture dedicated to ongoing enhancement.
2. Project Management: Manage all phases of R&D projects, ensuring they are completed on schedule, within budget, and uphold the highest standards of quality. Facilitate collaboration across various functional teams to reach project benchmarks.
3. Team Management: Direct and mentor a diverse team of engineers, scientists, and research staff, offering career development opportunities and fostering a workplace that promotes creativity and innovation.
4. Product Development: Lead the design and launch of new medical devices from inception through to market release, ensuring compliance with all regulatory standards and meeting clinical needs. Work collaboratively with teams from Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing to ensure successful product launches.
5. Regulatory Compliance: Guarantee all R&D activities adhere to applicable regulations and standards, including those set by the FDA and ISO. Partner with Regulatory Affairs to streamline the approval processes for new devices.
6. Risk Management: Identify, evaluate, and mitigate risks related to R&D projects, addressing technical, regulatory, and market challenges. Develop strategies to overcome potential hurdles to maintain project momentum.
7. Reporting and Communication: Regularly update executive leadership and stakeholders on the progress, milestones, and any obstacles within R&D projects through clear and effective communication.
8. Collaboration and Partnerships: Work closely with the R&D team in Birmingham and other internal teams. Build and maintain strategic relationships with external parties such as academic entities, research groups, and industrial partners to enhance R&D capabilities.
9. Budgeting and Resource Management: Administer the R&D budget and allocate resources judiciously to maximize efficiency and productivity across projects.
10. Intellectual Property Management: Oversee the protection and management of intellectual property arising from R&D, coordinating with legal teams to safeguard these assets.
11. Technology Assessment: Keep abreast of emerging technologies and industry trends, assessing their potential impact on existing products and exploring opportunities for new developments in collaboration with the Chief Technology Officer (CTO).

Qualifications:

• Master’s degree in Engineering, Biomedical Sciences, or a closely related field; a PhD is preferred.
• MBA with a specialization in finance or marketing.
• At least 10 years of experience in medical device R&D, particularly in dental implantology, with a track record of spearheading successful product developments.
• Profound technical knowledge in medical device design, development, and production.
• Comprehensive understanding of dental implantology, including cutting-edge technologies, market dynamics, competitors, scientific advancements, and workflows.
• Familiarity with significant regulatory standards and requirements, such as EU 2017/745, ISO 13485, and FDA regulations including 21 CFR Part 820 and Part 11.
• Exceptional leadership and team management skills, capable of motivating a multidisciplinary team.
• Robust problem-solving and decision-making skills with a strong orientation towards results and continuous improvement.
• Superior communication and interpersonal skills, proficient in English and German, enabling effective collaboration with both internal and external stakeholders.
• Experience with project management methodologies and tools such as Agile, Waterfall, MS Project, preferred.
• Proficiency in software tools including MS Office, Power BI, SAP, CAQ, among others.

This role is ideal for a visionary leader looking to impact the future of medical technologies through innovative development and strategic partnerships.