Job Title Senior Process Development Engineer
Reporting to: Senior Manager, Design & Engineering
The Senior Process Development Engineer will be responsible for leading the development of new manufacturing technologies in our product design and manufacturing business. During the development phase of the projects, he/she 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 optimize 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.
- Degree or equivalent in an engineering discipline, with 5yrs+ experience with manufacturing process design and optimisation within a highly regulated environment
- Previous experience of working within a medical device environment is essential.
- Proven ability to conceptualize and deliver innovative solutions.
- Experienced in using Six Sigma methodology for process improvement (e.g. DMAIC) and problem solving (e.g. 6-step approach).
- Experienced in statistical analysis and use of Minitab.
- Experience with manufacturing process design and optimization.
- 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 organized and have excellent planning and communication skills