LSC are looking for a Project Engineer required by a multinational medical device company based in Cork. The Cork facility is a global Centre for product development, manufacturing and supply chain. The product & process innovation Centre on site is a global strategic investment based on the skills and capabilities of the Cork staff. The site employs over 1000 persons and operates as a fast paced, innovative and highly collaborative international team. Our client is known for their leading edge product and manufacturing process innovation and ingenuity. This drive for excellence is coupled with a strong task focused team culture. If you like seeing your ideas come to life then contact us to learn more.
In this new role the Project Engineer will work with interact with H&S, Quality, Operations, Product Design and global packaging teams to develop the packaging process. You will own packaging related activity on the project or a process technology for multiple projects at the Cork Innovation Centre. The project team will develop, qualify and complete regulatory submissions of the manufacturing process capable of packaging implants to safety, quality, service and cost standards
- Execution and project management responsibility for packaging aspects of the semi-automated line
- Manage risk management and validation lifecycle for the packaging process change.
- Execution of the validation requirements for new process (Change Controls, IQ/ OQ/PQ).
- Conduct DOEs and Engineering Studies to ensure compliance
- Direct PFMEA studies and lead risk assessment effort for overall process
- A minimum of a Bachelor's degree in Engineering is required. A Masters or PhD is an advantage.
- Demonstrated validation experience/ exposure
- 1-3 years experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing
- Self-motivated, with focus on Quality, Delivery and Cost
If you think this exciting opportunity is the right fit for you, then please call Conor at LSC on 021 4777 329 for more information on this new Project Engineer position or apply directly via this advert.