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 his/her 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 clients full potential.
Responsibilities:
1. Develop design concepts and development options for company's next generation pVAD catheter
2. Develop assembly and manufacturing processes for the next generation catheter
3. Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans.
4. Development of DFMEA and PFMEA or similar risk management tools
5. Work with management and marketing function to ensure adequate input from physician advisors
6. 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
7. Ensure adequate IP generation to protect novel developments and findings
8. Manage relationships with third party development and manufacturing vendors
Required Qualifications & Characteristics:
9. Self-directed engineer with entrepreneurial drive
10. Have an established vendor network relevant to the device type
Experience in:
11. Development of cardiovascular or equivalent devices
12. Functional and mechanical test method development.
13. Polymer processing techniques
14. Flow mechanics and dynamics preferably.
15. Intimate understanding of interventional cardiology device requirements, preferably structural heart applications .
16. Excellent communication skills in English and preferably one other European language
17. Master's or primary Degree in a relevant engineering discipline, or equivalent experience
Additional Desirable Experience or Qualifications in:
18. Application of FEA and Theoretical modelling/analysis to support design decisions and development directions
19. Design for Manufacture methodologies apid prototyping techniques and proof of concept testing
20. Competency in Solidworks or equivalent 3D CAD system
21. Polymer processing and joining techniques
22. Use of statistical analysis techniques & DOE