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Life Cycle Management Specialist
3 weeks ago
Job Title: Medical Device Process Manager
">This role involves leading a multi-functional team in the development and production of medical devices used for treating strokes.
The successful candidate will work as a recognized manufacturing and process technical authority, providing process engineering knowledge and oversight.
The Technical Life Cycle Management and Engineering (TLCME) team collaborate with R&D to provide technical expertise for the production of acute ischaemic stroke devices.
The key responsibilities include:
- Demonstrating hands-on engineering skills in the development of new processes.
- Manufacturing & Project activity at contract manufacturing organisations, including product builds, quality issue resolution, process development, training, validation, and continuous monitoring of manufacturing performance.
- Providing leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts.
- Developing and implementing equipment and/or process improvements that enhance efficiency, product yield, and equipment reliability.
- Leading the implementation of new manufacturing processes and equipment to support the assembly of new products.
- Representing Supply Chain on strategic new projects, including breakthrough manufacturing technologies.
The ideal candidate should possess:
- A degree in Mechanical or Biomedical Engineering or equivalent.
- Proven experience within a GMP regulated Medical Device Industry.
- Project Management experience or alternatively be a key core team member as part of a project team.
- Experience in special processes, such as catheter assembly, polymer processing, metal processing, welding, equipment & tool design.
- People management experience leading a team of engineers.
The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards, while driving innovation and process improvements. This is an exciting opportunity for a skilled engineer looking to make a meaningful impact in the field of Medical Device Process Management.
