Technical Life Cycle Engineering Manager
The Technical Life Cycle Management and Engineering (TLCME) team is a crucial part of our organization's success, tasked with collaborating with R&D to provide technical expertise for the production of acute ischaemic stroke devices.
As a key member of this team, you will lead a multi-functional team in the development and production of medical devices used for the treatment of stroke. Your primary focus will be on leading manufacturing efforts, ensuring the successful transition to manufacturing using design for manufacturability concepts.
Responsibilities:
* Demonstrate proven hands-on engineering skills in the development of new processes to drive innovation and efficiency.
* Oversee Manufacturing & Project activity at contract manufacturing organisations, including product builds, product quality issue resolution, process development, technical training, validation, and continuous monitoring of manufacturing performance.
* Provide Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the implementation of equipment and/or process improvements that will improve efficiency, product yield, and equipment reliability.
* Lead the implementation of new manufacturing processes and equipment to support the assembly of new products, enhancing our capabilities and driving business growth.
* Represent Supply Chain on strategic new projects, identifying breakthrough manufacturing technologies that can benefit our organization.
Requirements:
* Hold a Mechanical or Biomedical Engineering degree or equivalent qualification.
* Possess proven experience within a GMP regulated Medical Device Industry, with a strong understanding of regulatory requirements.
* Have project management experience or alternatively be a key core team member as part of a project team, demonstrating your ability to work effectively in a collaborative environment.
* Bring experience in special processes, such as catheter assembly, polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, equipment & tool design.
* Have people management experience, leading a team of engineers to achieve common goals and objectives.