We are looking to recruit a Process Engineer who will be responsible for validation, development, and continuous improvement of production processes and related quality practices. The role will focus on ensuring that all processes are optimised, validated, and effectively controlled to maintain efficiency and compliance. The successful candidate will demonstrate a strong knowledge and understanding of process validation and have exposure to various manufacturing processes, such as injection moulding, blow moulding, extrusion, foam pouring, ultrasonic welding, manual and automated assembly, packing, and in-process testing. They will also have a proven track record of ensuring that processes remain stable and maintain their validated state in a production environment.

• Manufacturing Process Validation for Medical Devices
• Qualification or degree in Engineering discipline or equivalent level qualification
• Awareness of Product Qualification
• Understanding of Lean Manufacturing Principles
• Experience organising, supporting and carrying out trials
• Knowledge and understanding of validated processes preferably in a highly regulated manufacturing environment
• Demonstrable process engineering experience
• Experience in manufacturing and validation of processes and equipment
Desirable Experience/Qualification:
• Introduction to ISO 13485:2016 Medical Devices
• QMS Requirements ISO 9001:2015
• Experience in an automated manufacturing environment, Excellent verbal and written communication skills
• Able to work to deadlines
• Able to multitask and prioritise workload
• Able to make decisions and self-manage
• Able to work in a team and on own initiative
• Able to function effectively across a number of interrelated departments
• Able to work in a safe manner complying with Health and Safety Legislation
• Methodical, organised and structured approach to work
• Excellent attention to detail
• High level of commitment
• Flexibility to work additional hours if required to support the facility