Senior Technical Leader – R&D for Implantable Medical Devices

About the role

AbbVie is seeking a Senior Technical Leader to drive the design, development, and validation of implantable medical devices and related manufacturing processes. The role requires strong project management skills to coordinate cross‑functional teams and deliver solutions under tight timelines.

Key responsibilities

• Define R&D requirements, design new implantable devices, and implement design changes for existing products.
• Lead design, testing, documentation, implementation, and validation of device designs, equipment, and processes.
• Coordinate with Operations, Quality, Manufacturing, and contract manufacturers to develop cost‑effective manufacturing equipment and procedures.
• Transfer equipment and new processes to manufacturing sites, ensuring smooth start‑up within quality and cost constraints.
• Support change control, audits, CAPAs, complaint investigations, and regulatory inquiries.

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, with a strong background in design control and development processes.
• Fluent English (C1) and ability to work in a regulated FDA‑GMP environment.

Required skills

• Solidworks or AutoCAD
• Microsoft Office and Minitab
• Risk Management techniques such as FMEA
• Knowledge of GMP, QSR, FDA regulations, CAPA, ISO standards
• Technical writing and documentation