Job Title : Project Engineer, Clean & Pack NPI
Location: Cork, Ireland
Type : Permanent /Contract role
· On a daily basis your work in NPI will interact with H&S, Quality, Operations, Product Design and global packaging teams to develop this process to market launch. You will own either a process step in a project or a process technology for multiple projects at the Cork Innovation Centre.
· The project team will develop, qualify & launch a manufacturing process capable of making implants to safety, quality, service and cost standards.
· The Ideal Candidate: A planned and organised individual with strong technical or process knowledge/experience in a regulated industry.
· A strong background in validation and process documentation. Experience in cleaning & packaging within a regulated industry would be highly advantageous.
· A strong team player that will own the delivery of elements within their process/technology area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges.
· Process development and value engineering including PFMEA
· Process Characterisation
· Process Qualification/Validation
· Planning of key deliverables into action plans with the help of the Project Manager 5. Regular reporting on the status, performance and risks of your process / technology 6. Developing packaging technologies and processes 7. Participate in DFM reviews with Design Team to minimize lifecycle cost
· Minimise Environmental and Health & Safety effects of your work 9. Adhere to the company’s procedures as detailed in the SOP manual 10. Support Regulatory Affairs with product submissions
· All other duties as directed by direct manager
· Third level Engineering degree or similar discipline.
· 1-3 years’ experience in product / process development with Class II / III medical devices or another regulated environment.
· Self-motivated, with focus on Quality, Delivery and Cost. 3. Proven Root Cause analysis and problem-solving techniques
· 1-3 years’ experience in equipment operation/installation/qualification in a regulated environment.
· Exposure to Project Management
· Knowledge of medical device quality & regulatory systems
· Certified Six Sigma qualifications.
· Knowledge of anatomy and physiology
· Experience in cleaning and packaging processes and technologies