The Process Development Engineer will be responsible for leading the development of new manufacturing technologies in our Device Development product design and manufacturing business. During the development phase of the projects, they will work with the Project Development teams and during the product commercialisation with the Product Transfer team.
- Lead process development on development projects, working as part of the project team.
- Development and installation of new manufacturing and process technologies to support product development and product transfers.
- Apply new technologies and methodologies to optimise process design & performance.
- Establish processes based on product specifications in line with Unit Cost metrics.
- Evaluate process and design alternatives based on Design for Manufacturability principles.
- Understand principles of Lean manufacturing, problem-solving, DOE.
- Complete process validation for new processes and products including IQ, OQ, PQ & PPQ.
- Working with external vendors to specify, develop and commission new process technologies.
- Setting up of new manufacturing equipment/production lines including the selection and training of process technicians and product builders, as required.
- Responsibility for and understanding of work environment issues including H&S activities associated with new process development.
- Development of manufacturing processes from prototyping to full-scale production.
- The manufacture and testing of prototypes.
- Design/source equipment and tooling required to meet both the capability & capacity requirements.
- Generate work plans & schedules for development activity and execute to plan.
- Previous experience of working within a medical device environment would be a distinct advantage.
- Proven ability to conceptualise and deliver automated solutions.
- Experienced in using Six-Sigma methodology for process improvement (e.g. DMAIC) and problem-solving (e.g. 6-step approach).
- Level 8 degree or equivalent in an Engineering discipline.
- 3yrs+ experience with manufacturing process design and optimisation within a highly regulated environment.
- Experienced in statistical analysis and use of MiniTab.
- Experience with manufacturing process design and optimisation.
- Strong mechanical background with a good working knowledge of metals & plastics processing a distinct advantage.
- It is essential that the candidate will be highly innovative, motivated and organised and have excellent planning and communication skills.