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.
The Principal R&D Engineer will be an experienced medical device engineer with intimate knowledge of medical device development for interventional cardiology.
The key responsibility will be the development of the company's next generation pVAD catheter, including definition of device requirements, concept development, and proof of principle design, prototyping and test, design development and process development as well as supervising the selection and management of suppliers of catheter components.
The Principal R&D Engineer will work closely with counterparts responsible for procedure and test development, device characterization, as well as quality affairs and marketing functions.
He/She will share the responsibility of realising our client's full potential.
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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