Responsible for global Design & Technical Documentation of Trauma/CMF implants and instruments following European (MDD/MDR), US (510k) and other regulations.
Responsibilities
Designs and develops new implants and instruments and develops improvements and modifications to current products according to the DePuySynthes product development process
Responsible for the product design
Is primary contact person for technical questions/issues of existing products
Participates or leads development and/or product improvement projects
Interacts within cross-functional teams and supply chain and participates or leads process & product improvements
Works with surgeons, sales force and others for design requirements, design concept development, prototype and cadaver evaluation, and 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)
Develops 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.
Works with manufacturing during the design stages to incorporate manufacturability into the product designs and during the implementation phase to clarify design issues
Performs the required activities and generates 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
Performs other special projects and functions as assigned
Know and follow all laws and policies that apply to the job, and to maintain the highest levels of professionalism, ethics and compliance at all times
Qualifications
A minimum of BSc in a related scientific or engineering field.
A minimum of 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
