Principal r&d engineer, catheter development

Job Opening Title: Principal R&D Engineer, Catheter Development

Reports to: R&D Manager

About CardiacBooster: CardiacBooster 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. We are an enthusiastic team with diverse backgrounds and expertise, located in Galway, Ireland, Nijmegen, Netherlands and the United States. CardiacBooster is an equal opportunity employer.

Job Description: 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 CardiacBooster’s full potential. The successful candidate will have entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. He/She will have hands-on knowledge and experience in the development of cardiovascular devices. The Principal R&D Engineer will be a team player and have excellent communication skills as well as in-depth industry knowledge. The successful candidate will look back on a minimum of 10 years of medical device development experience, and have a either a primary or Master’s Degree in a relevant engineering discipline such as polymer, mechanical or biomedical engineering, or equivalent experience. The Principal R&D Engineer will work from the company’s office in Galway, and be able to travel occasionally.

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• 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
  

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• 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
  

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• 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
  

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel as classified.