Terumo Aortic are looking for a Product Development Engineer to join their Custom Device team. The successful candidate will be responsible for supporting the development of Class III medical devices through creation and administration of design history files and associated documentation Key Duties Design and development of custom devices Manage and prioritise workload across several live custom device cases to meet strict deadlines Innovation of new ideas & evaluation of concepts Problem solving Process development and continuous improvement Test development (Test protocols) Responsible for definition of design verification protocols, data analysis and report generation Ensuring that design activity is fully documented in line with company design control requirements Risk Analysis including dFMEA and ensuring that risk management system is compliant with regards to essential regulatory requirements for custom devices produced Generation of Engineering Drawings Generation of Bills of Materials Liaising with other relevant departments Presenting to and participating in discussions with clinicians on technical and general design/process matters including participation at workshops, congresses and other sales and marketing events to promote the products Liaising with other departments throughout the company to ensure design process is adhered to including quality, regulatory, manufacturing and sales and marketing functions Review and approval of custom device documentation including rationales, procedures and risk management paperwork Working to relevant quality standards Qualifications And Experience Engineering Graduate. BSc (or Equivalent) in Product Design Engineering, Mechanical Engineering, Material Science, or relevant discipline. Proven ability to work effectively as part of a team Clear and efficient communication skills Planning & organising skills with ability to work to deadlines Effective decision maker Effective presentation skills (MS Powerpoint) Ability to document work in line with Design control & Quality systems including FMEA Relevant previous experience