Director Global R&D
Michael Page
vor 11 Tg.
source :

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%
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