Entreprise : Our client is a global Medical Devices player dedicated to the diabetes management and self-care solutions. Description du poste :
Develop our client into an innovation driven organisation.
Develop the 5 and 10 year R&D road map of "make" and "buy" products - in cooperation with other departments of the organisation, incl.
marketing, that are expected to generate growth and build value.
Develop new ideas of medical device products in the key existing categories - blood sampling, drug delivery devices, etc.
lead development of new product ideas, lead development of ideas into tangible and verified concepts, turn concepts into prototypes.
Continuously provide a broader innovation perspective beyond the core product categories and capabilities - define the short, mid-
and long-term perspective for innovation in line with or even surpassing market trends within the broadly defined medical device space.
Ensure medical device prototypes are assessed from the manufacturability perspective in areas of metal, needle, cannula welding and grinding, spring winding, injection moulding, automation, material science -
optimal raw materials used for the characteristics of the product.
Ensure medical device concepts and prototypes are verified from the usability, end-user feedback, clinical perspective.
Conduct design in line with the medical device requirements, MDR, FDA, ISO standards, within the Quality Management System requirements. Description du profil :
Master's degree, preferably in engineering, medical device space.
Minimum of 10 years progressive experience in R&D - focused on medical devices.
Proven experience and track record in design and implementation of new medical devices in core categories (blood sampling, drug delivery devices, safety enabled medical devices, etc.).
Proven ability to look beyond and innovate in new categories.
Structured approach to new product development : from idea to concept; from concept to prototype, from prototype to final verified prototype and implementation to production.
Knowledge on the ISO, RA regulations (MDR, FDA, other), Quality Management system impact on the design requirements, process and appropriate documentation of the work in DHF,TF, V&V, Risk management, etc.
Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialisation.
A strong advantages would be :
Proven experience and track record in assessing manufacturability of the designs / prototypes and knowledge in the application of such technologies as : needle / cannula manufacturing / grinding, metal processing, spring winding, mass scale plastic injection moulding, automated assembly, automated packaging, sterilisation.
As well as impact of the above technologies / processes on the metal, paper and plastic raw materials being used for product design and production.
Experience in development of an organisational culture that promotes and sustains quality as an element of superior business performance.
Travel Requirements : International travel is required for this role 40-60%