Process Development Engineer (R&D)
This exciting opportunity is a key role within R&D and will take a hands-on role in the selection, generation and validation of new process technologies and the further development of existing processing methods. The Process Development Engineer will be a member of the product Development Team focusing on all process related aspects to ensure the generation and implementation of robust solution from a systems, Equipment and test perspective that will seamlessly transfer in to scale manufacturing.
THE ROLE ……
- Liaise with Project Leaders, R&D & Operations Team members and other internal customers to clearly understand requirements and inputs.
- Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure that process design is robust and reproducible and capable of meeting all qualification requirements.
- Ensure that Design for Manufacturability, capacity and product cost impacts are considered in all decision making such that design can be scaled seamlessly in to manufacturing at required product cost.
- Define and put in place drawings, BOM's and Routers and procedure to ensure the product design is translated accurately in to Manufacturing.
- Plan and execute risk assessment, process specification/ test methods development and subsequent Process Qualifications (IQ,OQ,PQ)
- Generate and maintain required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
- Provide Guidance to Junior Engineers and Technicians within the R&D Department.
- Performs other related duties and tasks as required.
- Degree in Engineering, related technical field or with appropriate demonstrated experience.
- At least 5 years previous related experience.
- Demonstrated analytical problem-solving abilities.
- Demonstrated ability in Process development, validation and statistical analysis.
- Experience in Metal processing & joining techniques and emerging process technologies an advantage.
- Good working knowledge of medical device materials and processes.
- Working knowledge of Solidworks and / or 3D modeling.
- Formal project management training an advantage.
- Good working knowledge of Microsoft Office including MS Project or similar.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.
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