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 ……

Main Duties/Responsibilities:

• 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.

Minimum Qualifications/Competencies:

• 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.