Senior Technical Leader – R&D

About the role

Leads projects in the design and development of implantable medical devices, accessories and related manufacturing processes. The role requires strong project management, technical expertise, and the ability to work under compressed timelines.

Key responsibilities

• Define R&D requirements and develop new implantable devices or enhancements for existing products.
• Design, test, document, implement and validate device designs, equipment and processes.
• Coordinate inter‑departmental and external resources to achieve company objectives.
• Support operations, quality, manufacturing and contract manufacturers in cost‑effective equipment and procedure implementation.
• Transfer equipment and new processes to manufacturing sites and ensure smooth start‑up within quality and cost constraints.

Required profile

• Bachelor’s degree or higher in Engineering, Industrial Engineering, Chemical Engineering or related field.
• Minimum 9 years of experience in the medical device industry.
• Fluent English (C1 level) and ability to work in a regulated FDA GMP environment.
• Strong technical writing and risk management skills.

Required skills

• SolidWorks or AutoCAD
• Microsoft Office
• Minitab (desirable)
• Knowledge of GMP, QSR, FDA regulations, CAPA, ISO standards
• Risk management techniques including FMEA
• Design for Manufacturability and testability principles