Terumo Aortic is looking for a Product Development Engineer to join their Research and Development team. The successful candidate will support the development of Class III medical devices through creation and administration of design history files and associated documentation.
Key Duties
* Part of a cross‑functional Product Development team, translating design inputs into new product designs that satisfy performance, manufacturability, quality and regulatory compliance.
* Participation in the innovation of new ideas and evaluation of concepts.
* Responsible for component/device design, including fully dimensioned CAD drawings, material selection meeting biocompatibility requirements, bill of materials and supplier liaising.
* Responsible for design‑related risk analysis (Design FMEA).
* Responsible for definition of Design Verification protocols, data analysis and report generation.
* Ensure design activity is fully documented per Design Control requirements.
* Internal liaison and knowledge transfer to manufacturing, QC, clinical services and marketing.
* Liaise with customers, including surgeons and medical professionals, to establish new product requirements.
* Plan and coordinate core team activities to ensure completion of deliverables in line with project plan.
* Lead discussions at design review; report to design review team regarding project time‑scales, costs etc.
* Have authority, accountability and day‑to‑day responsibility for delivering the 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 and development.
* Proven ability to work effectively as part of a team.
* Clear and efficient communication skills.
* Planning and organising skills with ability to meet deadlines (use of MS Project).
* Effective decision‑making ability.
* Effective presentation skills (MS PowerPoint).
* Ability to document work in line with Design Control and Quality systems, including FMEA.
* Generation of engineering drawings and 3D SolidWorks models.
Employment type: Full‑time.
Seniority level: Entry level.
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