
Senior Catheter Development Specialist
1 week ago
Our company is looking for a medical device engineer to support the development of innovative heart support devices for interventional cardiologists.
The ideal candidate will have intimate knowledge of medical device development for interventional cardiology and be experienced in the development of cardiovascular or equivalent devices.
Key responsibilities will include the development of next-generation pVAD catheters, including definition of device requirements, concept development, and proof of principle design, prototyping and testing, design development and process development as well as supervising the selection and management of suppliers of catheter components.
Key Responsibilities:
- Develop design concepts and development options for next-generation pVAD catheters
- Develop assembly and manufacturing processes for next-generation catheters
- 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
- Established vendor network relevant to the device type
Experience in:
- Functional and mechanical test method development
- Polymer processing techniques
- Flow mechanics and dynamics
- 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:
- 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
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