We have an excellent opportunity with a global Medical Device company in Berlin. We are recruiting for an R&D Engineer who will be responsible for global Design & Technical Documentation of Trauma/CMF implants and instruments following European MDD/MDR, US (510k) and other regulations. The position is focused on Lifecycle management.
* Oversee the entire Lifecycle management of Trauma and CMF impants; design and develop new implants and instruments and develop improvements and modifications to current products according to the product development process
* You will be the primary contact person for technical questions and issues of existing products
* Maintain a strong communication network with the cross-functional team and supply chain and participate in process & product improvements
* Develop strong relationships and work closely with surgeons, sales force and others for design requirements, design concept development, prototype and cadaver evaluation as well as clinical follow-up
* Responsible for initial patent review of designs for freedom to operate as well as for the protection of new concepts, techniques and products through proper patenting
* In close collaboration with the technical engineering office, generates product models, concept layouts, and prints using CAD software ProE/CREO.
* Responsible for the performance of the product and its mechanical stability, as well as the application of geometric dimensioning and tolerancing (GD&T)
* Develop mechanical test set-ups (including derivation of benchmarks) according to national and international standards and coordinates the activities required to fabricate test parts and Plan/execute mechanical testing in collaboration with Swiss and US test labs.
* Work with manufacturing during the design stages to incorporate manufacturability into the product designs and during the implementation phase to clarify design issues
* Perform the required activities and generate the appropriate technical documents to ensure compliance with national and international regulations related to medical devices (in particular EU MDD, EU MDR, US FDA, Japanese PAL)
* Responsible for implementing of new MDR requirements/documentation across Trauma/CMF products. Strong collaboration and interaction with Supply Chain – in EU as well as in US.
* Supports surgeons with regards to handling of implants/instruments and engineering-specific questions
* BSc or MSc in Engineering
* 3+ years of experience in product development and/or life-cycle-management of medical devices.
* Experience with documentation and Technical Files according to EU MDD and CFDA, MDR precognition preferred.
* Manufacturing background or profound manufacturing process know-how, experience in manufacturing of medical devices preferred.
* Good mechanical engineering skills combined with problem-solving and project management abilities.
* Profound knowledge of applicable European (EN), US (ASTM, etc.) and international (ISO, etc.) standards for medical devices
#Entwicklungsingenieur #ForschungsundEntwicklungsingenieur #orthopädisch #IMPLANTATE
Kontakt: Luchele Mendes + 41 44 215 20 51
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.