Terumo Aortic are currently looking to recruit a Technical Process Development Engineer to join our truly global business at a time of investment and expansion. This is a fantastic opportunity for someone to further develop their career whilst adding real value supporting the development, installation and validation of new processes for manufacture of product.
The main responsibilities of the role are;
- Support and Execute specific site investment program activities.
- Review, current processes, identify and develop improved methods and equipment for manufacture.
Identify and engage with internal and external suppliers as required.
- 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.
- Identify and deliver continuous improvement programs to deliver costs savings in line with overall manufacturing objectives.
- Liaise with all relevant departments on the transfer of new products into manufacturing and ensure appropriate specifications and packaging materials are available.
- Thorough knowledge of FMEA & DOE processes.
Develop, initiate, and manage implementation of ECO’s to address product quality, cost and design issues.
- Ensure that appropriate manufacturing test and validation is performed on materials and processes employed in the manufacture of products; ensure appropriate testing is performed to confirm the ‘fit & function’ of products.
Generate drawings when required and review/ approve artwork to ensure correct implementation.
- Ensure root cause investigations are carried out in response to product defects. Analyse and approve corrective actions proposed to address quality issues.
- Monitor field response to confirm effectiveness of implemented corrective actions.
- 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.
- Assess opportunities for transfer of product manufacture from inter-company and to contract manufacture. Facilitate the transfer of manufacturing process knowledge and technology to allow product relocation.
- Participate in QS audits of manufacturing; ensure appropriate action is taken in response to audit findings.
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.
- Support provisions of quality data/reports/charts for the manufacturing group.
- Generate Quality input for supplier performance management process.
- Generate relevant required documentation in support of regulatory updates and filings.
- Perform any other duties/tasks/ projects as required by management.
- Assume other responsibilities from time to time to support plant’s strategic plan and personal career plans.
The successful candidate will possess;
- Minimum HND or equivalent in relevant engineering experience
- Relevant previous experience in a high-quality manufacturing environment
- Knowledge of process design, engineering and process maintenance
- Ability to work on own initiative. Can take a problem, analyze it and put an action plan in place.
- Ability to conceptualize and develop process solutions and improvements (Jigs, fixtures, tooling, process equipment & machinery)
- Problem solving and strong analytical skills
- Ability to work with minimum supervision
- Proven project management experience
- Solid manufacturing engineering experience is essential
- Experience of automated processes, vision inspection, Co-bots or similar desirable.
- Experience of Lean manufacturing principles, ie SMED, VM, 5S etc would be advantageous
- Strong computer skills and industry knowledge