Terumo Aortic are seeking an experienced Specialist Senior Engineer to lead the technical aspects of product development and R&D projects in compliance with relevant procedures, including the adoption of new techniques and analysis methodologies.
As an Engineering Lead Innovation you would lead the team in the SCF Process, in collaboration with marketing, to identify Innovation opportunities and develop Proof of Concept prototypes for new products and services (mainly Class III medical devices) to meet user needs, technical feasibility and commercial viability requirements.
Lead the team in driving new IP development and maintaining up to date information for R&D on relevant IP Landscapes.
The Key Responsibilities Are
- Line management responsibility for a team of engineers and technicians
- Lead Advanced Design 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 the innovation of new ideas & evaluation of concepts
- Lead team in the Strategic Concept Filter Process
- Lead prototyping team, in collaboration with CAD team, to produce proof of concept prototypes
- Liaison with customers including surgeons and medical professionals to establish new product requirements
- Lead team in research (including support of Academic Collaborations) to ensure in-depth understanding of clinical problems and potential solutions, with knowledge transfer across the department, to drive Innovation.
- 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
- Lead team in completing SCF deliverables and participating in Strategic Review Team and Product Pipeline Prioritisation team
- Responsible for leading team in IP-related activities, including liaising with inventors and IP counsel to file new NIDs and support patent application processes
- As required, authority, accountability and day-to-day responsibility for leading and delivering projects in line with agreed objectives
- Accountable to Director of Research and Innovation 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 (SolidWorks), Excel and Word
- Clear and efficient communication, presentation and reporting skills are essential