Safety Risk Management Engineer - Medical Device Development

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Hillerød

Are you ready to play a key role in Novo Nordisk’s medical device development projects and help improve the life of our patients? In this position you will get a unique opportunity to use your educational and professional background to bring medical devices from development to the market by solving a wide range of challenges in collaboration with many stakeholders across the Novo Nordisk organization. If this interests you, then apply now! The Position: As our new Safety Risk Management Engineer, you will play a central role in the development of our medical devices. You will take part in one or more development projects spanning from early phase to submission and production. You will be interacting with many stakeholders across the organization, such as regulatory affairs, system engineering , mechanical engineering , SW/HW engineering and usability engineering , to drive the safety risk management activities. Your main tasks will include:
  • Taking part in cross-functional development projects based on one of our existing pen-injector platforms, securing the delivery of new variants to the market.
  • Safety risk analyses and documentation of the safety risk management process. This is to ensure the medical device is safe to use by patients and users and can be approved by regulatory bodies.
  • Working with a large range of internal and external stakeholders where you will play an important role in aligning these stakeholders across professional areas of expertise.
  • Planning and coordination of safety risk management deliverables, to ensure overall project timelines are met.
  • Preparation of documents for submission with health authorities and supporting the subsequent regulatory interactions.
  • Involvement in various improvement projects to further develop the safety risk management domain.
    • Qualifications:
  • Master’s degree or equivalent within engineering or natural science
  • Some years of experience from working with either development of medical devices (and/or combination products), or risk management in other regulated industries.
  • Professional proficiency within oral and written English is essential.
    • As a person you are collaborative and use your great interactive skills to converse openly, reach out to stakeholders across the organization, and facilitate meetings and workshops to reach decisions and ensure progress. You are analytical , structured and flourish on being detail-oriented while also being able to see the bigger picture. You are a strong team player recognised for your interpersonal skills. You bring a "can do" spirit, a healthy common sense, and a good sense of humour to your work. About the Department: In the Risk Management department, we are approximately 20 highly skilled and curious professionals and specialists divided into two teams, that have Safety Risk Management as the common denominator. Safety Risk Management underpins many aspects of medical device development, so our work is integrated into various processes within the development and manufacturing landscape, and our stakeholders have backgrounds in a variety of engineering and scientific disciplines. We are part of the Novo Nordisk Devices & Delivery Solutions unit, which is the organization responsible for the development of device solutions for medical self-treatment within all business areas of Novo Nordisk. In our department we have a wide range of development projects in different phases that we contribute to – from connected devices to purely mechanical pen- and auto-injectors. Our main aspiration is to further advance our offerings to people living with chronic diseases and their healthcare professionals through new technologies. Our department has a focus on being the best at what we do, but making sure that we have fun during the process. You will join a dynamic, international and innovative environment, where highly skilled professionals work closely together to develop next generation medical devices. Together we drive change At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact: For further information, please contact Cathrine Berg Larsen on [email protected] or mobile phone +45 30794289. Deadline: Please apply before the 22 October 2023. We are screening candidates and conduct interviews on an ongoing basis. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    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 16.8.2023, men kan have været deaktiveret og genaktiveret igen.

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