We are seeking a visionary Senior Development Engineer to lead the creation of a cutting-edge heart support device. This innovative product will stabilize patients in times of cardiogenic shock and acute heart failure.
The successful candidate will oversee the development of a next-generation pVAD catheter, including defining device requirements, concept development, and proof-of-principle design. They will be responsible for supervising supplier selection and component management while collaborating closely with counterparts responsible for procedure and test development, device characterization, quality affairs, and marketing functions.
Key Responsibilities:
* Design and develop novel solutions for the next-generation pVAD catheter
* Establish efficient assembly and manufacturing processes for the catheter
* Analyze risks and challenges; implement mitigation plans proactively
* Develop risk management tools such as DFMEA and PFMEA
* Collaborate with management and marketing to ensure physician advisor input
* Implement a rigorous design development process based on clinical use and loading conditions
* Ensure adequate intellectual property generation to protect novel developments and findings
* Manage relationships with third-party vendors for development and manufacturing
Required Skills & Qualifications:
* A self-directed engineer with entrepreneurial drive and vision
* An established network of relevant vendors
Desirable Experience or Qualifications:
* Development of cardiovascular or equivalent devices
* Functional and mechanical test method development
* Polymer processing techniques
* Flow mechanics and dynamics preferably
* In-depth 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