Gem job

System Engineer for novel stem cell devices

Novo Nordisk is on a mission to bring novel stem cell therapies out to people in disease areas with large unmet needs. We need you in our journey!

Do you want to combine your technical expertise within medical devices with project management responsibility leading to launch of new class of medical devices for stem cells? Then this is the role for you.

The position

You will be responsible for product development of medical devices for our cell therapies. It will involve work from early phase research to commercial launch, and you will be responsible for coordinating R&D tasks and projects.

In the role as System Engineer your main tasks will be:

  • Driving the technical progress of the stem cell device towards product commercialisation,
  • Driving the establishment of key technical documentation (hands-on and together with relevant expertise), etc product risk management, biological evaluations, product profile,
  • Working closely with stem cell research, stem cell CMC to test and validate the delivery of cells,
  • Cooperating with clinical development to mature the device for a clinical trial (first-human dose),
  • Leading the technical progress of activities requiring inputs from various functions/specialities,
  • Collaborating closely with internal engineering team, as well as external partners.
  • Qualifications

    The ideal candidate has the following requirements:

  • An engineering or science degree,
  • A minimum of 5-7 years of product development of class II/III medical devices,
  • Experience in leading technical tasks involving a multi-disciplinary team,
  • Experience in scoping, executing and authoring key product development documents.
  • Furthermore, it is considered an advantage if you have:

  • Experience developing devices for cell therapies,
  • Experience in working with external academic and industry partners,
  • Experience in interacting with regulatory bodies, and experience in transferring products into manufacturing.
  • The department

    The department of Stem Cell R&D Devices is a newly established unit within the Stem Cell R&D area. The unit consists of device project managers and key specialist areas such as system engineering, risk engineering and biomedical engineering needed to progress devices to clinic and later to the market. The unit is located within the broader stem cell area and works closely together with other research and clinical competency areas. Also, the unit collaborates with multiple external partners and each team member expected to engage with both internal and external stakeholders.

    Gem job

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