The scope of the role is to manage all engineering aspects of Drug Delivery Device design and development - from product concept through to a fully commercialised product.
> Working with internal teams and external partners, the Device Specialist will manage all aspects of the device development process from feasibility to ultimate manufacture Leading and delivering large technical work programs with a cross-functional team
> Technical project management of all aspects of the design process
> Conduct technical reviews during the development of new products
> Apply mechanical design knowledge
> Work with other members of the product development and ETT to deliver work programmes
> Produce Technical reports, project update reports for the product development team
> Management of external partners (Design Consultants / Specialist test consultants)
> Technology Transfer – manage the design transfer of all specifications, design and development history documentation from R&D to GMD
> Support design verification testing activities
> Generation of documentation suitable for submissions to ensure compliance to relevant regulations
> Liaise with internal departments (GMD / GMD QA/ R&D QA&QC).
> Degree in Engineering or similar technical discipline
> Minimum 5 years of experience in a similar position delivering medical devices. Preferably, with drug device combination products such as DPI or pMDI
> Good knowledge of Device Development processes, drug-device combination products and associated regulations would be an advantage. The ability to manage several projects to demanding timelines within a pharmaceutical environment.
> Fast Learning;
> English - Excellent.