Our company specializes in developing heart support devices for interventional cardiologists to stabilize patients in times of cardiogenic shock and acute heart failure. We are looking for a skilled engineer to lead our R&D efforts in catheter design and development.
Key Responsibilities
* Develop innovative design concepts and development options for next-generation pVAD catheters.
* Establish efficient assembly and manufacturing processes for the next-generation catheter.
* Anticipate risks and challenges; ensure mitigation plans are in place to minimize downtime and costs.
* Apply DFMEA and PFMEA risk management tools to identify potential issues and implement corrective actions.
* Collaborate with cross-functional teams to gather input from physician advisors and stakeholders.
* Design rigorous development processes based on clinical use and loading conditions, translating into robust component/sub-assembly specifications and testing.
* Ensure adequate intellectual property generation to protect novel developments and findings.
* Manage relationships with third-party vendors for development and manufacturing services.
Required Qualifications & Characteristics
* A self-directed engineer with entrepreneurial drive and a passion for innovation.
* 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.
* A Master's or primary degree in a relevant engineering discipline, or equivalent experience.