Our client is a global leader in the design and development of drug-delivery devices across a multitude of therapeutic areas. As they continue to expand their footprint in Ireland there has been significant investment in laboratories and workshops at their R&D hub in North Dublin. Having worked through a large business wide transformation and change programme, the Team are keen to attract an experienced leader who can drive their agenda forward.
The device development business unit is made up of over eighty staff who work to deliver high quality, robust and effect industry leading device and combination products to global markets.
The Senior Manager - Device Development & Industrialisation is directly responsible for managing the product lifecycle from early conceptual design through to scale-up design for manufacture.
Work within a multidisciplinary design team to lead tooling strategies suitable for transfer from pilot scale to high-volume manufacturing.
Lead the Team to produce robust, cost-effective designs of components and assemblies.
Oversee the preparation of component specifications.
Provide technical leadership and coaching for the Design Engineering Team across component design, quality, engineering, and continuous improvement initiatives.
Have oversight of engineering related issues and improvements including review and approval of manufacturing blueprints for components and equipment.
Provide design support to the manufacturing operations across multiple sites.
Work to de-risk the product industrialisation process by delivery practical solutions to achieve optimum performance in alignment with manufacturing requirements.
Liaise with functional support groups and encourage collaborations, both formal and informal, between the Team and other departments.
Hold minimum of a bachelor's degree (or equivalent) in a relevant discipline and a minimum of 8 years' experience in a leadership role.
Knowledge of tooling and moulding is highly desirable.
Possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.
Display strong written and oral communication skills.
Demonstrate familiarity with design principles for ISO13485 and FDA 21 CFR Part 820.
Must be able to work collaboratively and within multi-disciplinary project teams to ensure alignment.
Have a demonstrated track record of successfully developing, managing and executing projects from cradle to grave.
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 752 1041 for a confidential discussion.