Technical Development Engineer
CurrentTechnical Development Engineer for Terumo Aortic Ltd, supporting and executing site investment project - Final Pack. I ensure the development of Final Pack project is stable, effective and manufacturing processes are well documented. Activities include:- Ensuring delivery of processes meet all Product, Customer, Regulatory and Quality requirements.- Identify continuous improvement opportunities within the processes for structured implementation.- Improvement opportunities… Show more Technical Development Engineer for Terumo Aortic Ltd, supporting and executing site investment project - Final Pack. I ensure the development of Final Pack project is stable, effective and manufacturing processes are well documented. Activities include:- Ensuring delivery of processes meet all Product, Customer, Regulatory and Quality requirements.- Identify continuous improvement opportunities within the processes for structured implementation.- Improvement opportunities within the processes for structured implementation- Plan, compile and execute validation strategies (including documentation, reports, etc) to confirm suitability for use, and ‘fit and function’ of process outputs. - Support Development SOP’s Wi’s and Procedures as required. - Continually review all manufacturing processes to document, measure, refine and improve process capability and effectiveness. - Liaise with all relevant departments on the transfer of new products into manufacturing and ensure appropriate specifications and packaging materials are available. - Ensure root cause investigations are carried out in response to product defects- Generate relevant required documentation in support of regulatory updates and filings. - Support the QS group in development of a Quality System structure in line with revised IS13485:2016; ensure manufacturing compliance to applicable regulatory laws and requirements.- Participate in QS audits of manufacturing; ensure appropriate action is taken in response to audit findings. - Identify cost savings opportunities in materials and processes; plan and perform testing to validate changes that capitalise on these opportunities; document and release these changes. - Generate drawings when required and review/ approve artwork to ensure correct implementation. - Thorough knowledge of FMEA & DOE processes. Show less