Terumo Aortic are looking for a Product Development Engineer to join their Research and Development 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
1. Forming part of a cross functional Product Development team, with responsibility for the translation of design inputs into new product designs that satisfy the requirements of product performance, manufacturability, quality and regulatory compliance
2. Participation in the Innovation of new ideas & evaluation of concepts
3. Responsible for component or device design, including fully dimensioned CAD drawings, material selection meeting biocompatibility requirements, bill of materials, supplier liaising, etc.
4. Responsible for design related Risk Analysis (Design FMEA)
5. Responsible for definition of Design Verification protocols, data analysis and report generation.
6. Responsible for ensuring that design activity is fully documented per Design Control requirements.
7. Internal liaison and knowledge transfer to manufacturing, QC, clinical services and marketing
8. Liaison with customers including surgeons and medical professionals to establish new product requirements.
9. Responsible for planning and coordinating core team activities to ensure completion of deliverables in line with project plan
10. As required, lead discussions at design review, report to design review team regarding project timescales/ costs etc
11. As required, authority, accountability and day-to-day responsibility for delivering project in line with agreed objectives
12. Accountable to R&D manager for implementation of project plan
Qualifications and Experience
13. Engineering Graduate. BSc (or Equivalent) in Product Design Engineering, Mechanical Engineering, Material Science, or relevant discipline.
14. Relevant previous experience.
15. Proven ability with component design & development.
16. Proven ability to work effectively as part of a team.
17. Clear and efficient communication skills.
18. Planning & organising skills with ability to work to deadlines. (Use of MS project)
19. Effective decision maker
20. Effective presentation skills (MS Powerpoint)
21. Ability to document work in line with Design control & Quality systems including FMEA
22. Generation of Engineering Drawings 3D Solid Works