Overview

This role leads the end-to-end development of medical devices and combination products, from early concept through to global regulatory approval. The Device Development Lead oversees multidisciplinary project teams, manages external design partners, ensures compliance with device regulations, and drives successful delivery of device programmes.

Key Responsibilities

Project Leadership

* Lead multidisciplinary project teams in the development of drug delivery devices and lifecycle management activities.

* Manage project scope, timelines, quality and cost across assigned device programmes.

* Coordinate closely with formulation, manufacturing and co-development teams to support integration of devices into broader product development plans.

Device Development & Design Control

* Take full accountability for all stages of device development, including:

* Concept evaluation & Design development & Risk management

* Industrialisation and transfer to manufacturing

* Apply design control principles and ensure all activities meet regulatory and quality system requirements.

* Support the device change control process and ensure timely, compliant implementation.

External Partner Management

* Manage design and development activities carried out by external design houses and contract manufacturing organisations.

* Provide input on supplier specifications, component requirements and technical c...