About the Role
We are seeking a highly skilled R&D Engineer to join our Vascular division, contributing to a pioneering program. This is a newly launched initiative aimed at developing a Class III implantable device, with global ambitions including FDA PMA approval and clinical trials. You will be part of a multidisciplinary team working across three core components of the device: stent, graft covering, and delivery system. This role specifically focuses on the design and development of the delivery system, from early-stage concept through to commercialization.
Key Responsibilities
* Lead the design and development of the delivery system ensuring alignment with clinical and regulatory requirements.
* Collaborate with cross-functional teams across Europe and the US to drive innovation and technical excellence.
* Apply deep understanding of biomaterials and medical-grade materials to inform design decisions.
* Conduct and interpret bench testing, including compression, cling, and performance testing.
* Manage design documentation including design history files, risk assessments, and verification & validation protocols.
* Ensure compliance with design controls and regulatory standards throughout the product lifecycle.
* Support clinical study preparation and contribute to regulatory submissions.
Your Profile
* Minimum 4 years of engineering experience in the Class III medical device sector.
* Proven expertise in delivery system design, ideally for aortic, coronary, or vascular stent grafts.
* Strong knowledge of biomaterials, their properties, and applications in implantable devices.
* Hands-on experience with mechanical testing and performance validation.
* Familiarity with design control processes, including design input/output, risk management, and V&V.
* Degree in Biomedical Engineering, Mechanical Engineering, or Material Sciences.
* Excellent communication skills and ability to present technical concepts clearly.
* Fluent in English
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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