Terumo Aortic are looking for an experienced Product Development Engineer to join their Research and Development Team. The successful candidate will be responsible for the Engineering Design, Development and support of products (mainly Class III medical devices) in accordance with all relevant procedures. The ideal candidate would have experience in a similar role in a similar field as well as qualifications and experience mentioned below.
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, Quality, 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 Head of Innovation, Hybrid & Endovascular for implementation of project plan
Qualifications and Experience
Engineering Graduate BSc (or Equivalent) in 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 Edge, Solid Works)