R&D manger

R&D Manager – Medical DevicesRole Summary

Pylon Medical is seeking an experienced R&D Manager to lead the development of a novel, minimally invasive carotid access and closure platform. This role is hands-on and leadership-oriented, owning product development from advanced R&D through verification & validation (V&V), preclinical, and clinical readiness as the company advances toward First-in-Human (FIH) studies.

Success in this role means delivering robust, clinically ready designs on schedule, leading effective V&V execution, maintaining strong design control documentation, and enabling smooth progression into clinical studies and regulatory submissions. The R&D Manager will help scale the R&D function while ensuring technical excellence and compliance in a fast-moving startup environment.

The R&D Manager is a key leadership position within Pylon Medical, working closely with the CEO and collaborating cross-functionally with Clinical, Regulatory, QA, and Manufacturing teams. This role plays a central part in shaping the company’s technology, development strategy, and clinical execution.

• Lead R&D activities from advanced development through design freeze, V&V, and clinical readiness
• Plan, execute, and document verification & validation testing, bench testing, and preclinical studies
• Own and maintain design control documentation in compliance with ISO 13485 and FDA requirements
• Design and develop mechanical and system-level components of disposable medical devices
• Collaborate cross-functionally with Clinical, Regulatory, Quality, and Manufacturing teams to ensure alignment and execution
• Coordinate with external vendors, consultants, CROs, and key opinion leaders (KOLs)
• Mentor and manage engineers and technicians as the team grows
• Support preparation for regulatory submissions and clinical trials

• B.Sc. or M.Sc. in Mechanical Engineering or a related field
• 8+ years of experience in medical device research and development
• Proven experience taking products from concept through preclinical and/or clinical stages
• Strong understanding of design controls, V&V, and development in regulated environments
• Hands-on experience with SolidWorks
• Solid background in mechanical design, materials, and manufacturing processes
• Experience working in a startup environment — an advantage
• Excellent verbal and written communication skills in English