Risk Engineer

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Hillerød

  • Engineering
  • Hillerød

Are you an ambitious subject matter expert within class III medical devices and ideally have experience with stem cells? Would you like to join the Novo Nordisk team responsible for development of class III devices and to bring your experience and knowledge to the table? If yes, this role may be for you.

The position

As Risk Engineer you will join our team responsible for development of class III medical devices. You will be responsible for concept development, product development and documentation with a focus on:

  • Ensuring product risk management within stem cell device projects,
  • Ensuring risk management is an integrated part of device development and ready for later regulatory approval,
  • Preparation of risk related documentation,
  • Managing project risk activities in Stem Cell device projects,
  • Ensuring aligned risk evaluations across projects,
  • Performing risk evaluation of concepts and technologies,
  • Evaluating of new external regulatory signals in relation to risk management,
  • Conducting peer reviews within mechanical construction and safety related design issues,
  • Building up technical files according to the procedure.

Qualifications

To be successful in this role you need to have:

  • PhD with 4-5 years of relevant experience, M.Sc. with 5-7 years of relevant experience or B.Sc. with minimum 10 years relevant experience,
  • Development of Class III medical devices in general,
  • Deep understanding of risk deliverables.

Additionally, skills within several of the following fields are expected:

  • Stem cell delivery,
  • 3D modelling tools,
  • Polymers or material science related to efficacy and safety of a device,
  • Concept development,
  • Development of risk processes and analysis methods,
  • Planning and follow up with suppliers of materials, components, and services,
  • Project coordination,
  • Demonstrated impact of competences and knowledge deployed critical to execution of core processes in the broader area,
  • Presentations and professional communication,
  • Stakeholder management.

As a person, you are flexible and adaptable as the tasks are multiple, variable and the priority of projects may change and may range from specialist oriented to the more general. You are ready to adjust your schedule leading to overtime when met with periods of increased workload. You are fluent in written & spoken English.

About 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 specialist areas such as system engineering, risk engineering and biomedical engineering needed to progress devices to clinic. The unit will work closely together with stem cell biologists, formulation experts and clinical teams to progress the stem cell product. Also, the unit will have a significant external interface working with several external device partners. It provides a diverse workday working with different competency areas and partners in- and out-side Novo Nordisk.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

For further information you can contact Kristian Kolind on +45 30794374.

Deadline

10 January 2021

Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified.

Warning!:
Our recruitment system is undergoing system maintenance starting December 18, 2020 and continuing intermittingly through early January 2021.
If you are interested in applying for this position, we ask that you submit your application prior to the system maintenance period and pay close attention to job posting deadlines.
18.Dec 20.00 CET– 22.Dec 08:00 CET
31.Dec 20.00 CET – 4.Jan 08:00 CET
In early January, once our recruitment system is available, all positions that are accepting applicants will be available for your consideration and application.
We understand that this can be frustrating and thank you for your understanding and patience. To stay updated on system availability, kindly visit novonordisk.com/careers.

#LI-AMS

Millions rely on us

To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Hillerød.

Jobbet er oprettet på vores service den 25.11.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Hillerød
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