Overview
Our client is a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of cardiogenic shock and acute heart failure.
Responsibilities
Develop design concepts and development options for company’s next generation pVAD catheter
Develop assembly and manufacturing processes for the next generation catheter
Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans.
Development of DFMEA and PFMEA or similar risk management tools
Work with management and marketing function to ensure adequate input from physician advisors
Develop rigorous design development process based on in-depth understanding of clinical use and loading conditions. Translate this into robust component/sub-assembly specification and testing
Ensure adequate IP generation to protect novel developments and findings
Manage relationships with third party development and manufacturing vendors
Required Qualifications & Characteristics
Self-directed engineer with entrepreneurial drive
Have an established vendor network relevant to the device type
Experience in
Development of cardiovascular or equivalent devices
Functional and mechanical test method development.
Polymer processing techniques
Flow mechanics and dynamics preferably.
Intimate understanding of interventional cardiology device requirements, preferably structural heart applications .
Excellent communication skills in English and preferably one other European language
Master’s or primary Degree in a relevant engineering discipline, or equivalent experience
Additional Desirable Experience or Qualifications in
Application of FEA and Theoretical modelling/analysis to support design decisions and development directions
Design for Manufacture methodologies rapid prototyping techniques and proof of concept testing
Competency in Solidworks or equivalent 3D CAD system
Polymer processing and joining techniques
Use of statistical analysis techniques & DOE
For more information on this role please contact Christopher O Toole.
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