J
D
DOC No:
Issue No
CCR:
Eff Date:
FMG050
04
434
05/03/14
Job Title:
Responsible to:
Lead R&D Engineer
Technical Director
Job Purpose:
 To support th e company’s new product research and development programme and provide technical expertise and solutions in early stage product ideation, design, development and realisation. To work within a cross functional project team ensuring critical project deliverables are met.
Main Accountabilities:
• Concept Generation, Evaluation and Documentation.
• Responsible for complex computational fluid dynamic modelling & testing.
• Liaison with commercial and academic partnerships to facilitate pre-clinical testing.
• Responsible for component or device concept design, including fully dimensioned CAD drawings.
• Creation of regulatory compliant SOP’s, Protocols & Reports.
• Liaison with tool/model/component manufacturers to ensure timely and accurate translation of ideas.
• Responsible for ensuring that design activity is fully documented per Design Control requirements.
• Development and deployment of suitable testing methods and equipment for new proof of concept prototypes
• Liaison with surgeons and medical professionals to establish new product requirements.
• Translation of marketing and clinical information regarding User Needs into clearly defined design inputs
• Clinical literature review
Quality System Requirements:
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The employee agrees to adhere to all company policies and the Quality Management System.
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Experience:
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Formal engineering qualification would be advantageous (for example BEng or equivalent in
Mechanical Engineering, Product Design Engineering, Biomechanical Engineering or another relevant discipline)
In depth experience with Computational Fluid Dynamic modelling & testing
Experience working to regulatory guidelines e.g. ISO 13485 & US Quality System
Relevant previous medical device design & development experience, preferred but not essential
Proven ability with component & product design & development.
Proven ability to work effectively as part of a small dynamic cross functional team.
Clear and efficient communication skills.
Planning & organising skills with ability to work to aggressive deadlines.
Ability to document work in line with Design Control & Quality systems.
Generation of Engineering Drawings & 3D Models
This document is the property of Vascular Flow Technologies Limited. It must not be copied, in whole or in part, or otherwise disclosed, without prior written consent. Any copies of this document, or part thereof, must also include a copy of this legend. This document is supplied without liability for errors or omissions.
© Copyright Vascular Flow Technologies Ltd.

J
D
DOC No:
Issue No
CCR:
Eff Date:
FMG050
04
434
05/03/14
Job Title:
Responsible to:
Lead R&D Engineer
Technical Director
Competencies:






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2 yrs experience of product research & development within the Medical Devices Field
Subject matter expert in CFD
Proficiency in: MS Project, Solidworks & FEA
Experience in a dynamic environment, planning and facilitating research & development activities to a successful conclusion
Experience of Class 2b and 3 Medical Devices
Operation under an ISO 13485 Quality System
Understanding and implementation of Stage Gate Process
This document is the property of Vascular Flow Technologies Limited. It must not be copied, in whole or in part, or otherwise disclosed, without prior written consent. Any copies of this document, or part thereof, must also include a copy of this legend. This document is supplied without liability for errors or omissions.
© Copyright Vascular Flow Technologies Ltd.