Terumo Aortic are seeking an experienced Engineering Lead - Pipeline, who would be responsible for leading the team responsible for R&D work associated with the NPI Pipeline development of New Surgical and Hybrid Products.
As an Engineering Lead Pipeline you would lead the team in all Product Development activities related to the introduction of New Products to the Surgical and Hybrid product portfolio. In collaboration with the assigned cross functional core teams, identify, prioritise and execute the required R&D based workload related to Surgical and Hybrid NPI. Specifically, the development of new variants for TH or GW custom programs and Pioneer grafts.
Lead the team in identifying new opportunities and improvements that can be implemented through design to improve the market appeal and accessibility of the existing commercial product portfolios.
The Key Responsibilities are;
* Line management responsibility for a team of engineers and technicians
* Lead 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
* Lead team in driving new ideas & evaluation of concepts that could benefit the existing custom or pioneer portfolio.
* Liaison with customers including surgeons and medical professionals to establish new or customised products.
* Responsible for leading team in design activities, including production of fully dimensioned CAD drawings, material selection meeting biocompatibility requirements, supplier liaising, prototyping and evaluation testing, design related Risk Analysis (Design FMEA), definition of Design Verification protocols, data analysis and report generation. Responsible for ensuring that design activity is documented per Design Control requirements
* Internal liaison and knowledge transfer to Manufacturing, Quality, Clinical Services and Marketing where appropriate, including support for clinical introduction of new designs.
* As required, authority, accountability and day-to-day responsibility for leading and delivering projects in line with agreed objectives
* Accountable to Pipeline R&D Manager for Surgical and Hybrid for creation and implementation of project plan.
The Successful Candidate Will Possess
* Degree level qualification, minimum of BSc (or equivalent) in Product Design Engineering or other relevant Engineering Design discipline, MSc preferred
* Significant experience in development of Class II/III Medical Devices, preferably vascular devices, with a track record of achievement
* Experience leading Design Thinking processes to develop and evaluate new product concepts to meet user needs
* Extensive experience of hands-on prototyping and testing
* Experience of IP (patent searching, landscaping and NID filing) would be beneficial
* Strong interpersonal, planning and organisation skills
* Basic understanding of manufacturing processes used to produce Open and Endovascular devices
* Experience of leading a team would be beneficial
* Working knowledge of CAD (Solid Works), Excel and Word
* Clear and efficient communication, presentation and reporting skills are essential