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