Process Engineer (Medical Device)

Job Description

• 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 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.
• Design/source equipment and tooling required to meet both the capability & capacity requirements.
• Review and update of current Preventive maintenance practices and procedures
• Liaise with the supplier to optimize equipment design.
• Complete equipment validation including URS, FDS,FAT, EIQ, EOQ...
• Generate work plans & schedules for development activity and execute to plan
• Review and update of current Preventive maintenance practices and procedures.
• Liaise with the supplier to optimize equipment design.

Key Requirements

• Previous experience of working within a medical device environment would be a distinct advantage.
• 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 optimizations
• 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.
• Experience with equipment validation procedures.
• It is essential that the candidate will be highly innovative, motivated and organized and have excellent planning and communication skills.