Experienced Systems Engineer

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Hillerød

Are you ready to play a key role in Novo Nordisk’s development projects and help improve patient outcomes? Would you like to develop the next generation of medical devices for a variety of chronic diseases? In this position you will get a unique opportunity to use your engineering background to design medical devices and bring them from development to the market.
The Position

As our new experienced Systems Engineer you will play a central and leading 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 and be key in integrating the many technical disciplines into a coherent approach. You will be interacting with many stakeholders across the organization, such as regulatory affairs, safety risk management, mechanical engineering, SW/HW engineering and usability engineering, to drive the systems engineering and product integration activities. Having the systems-overview you will also be an important partner to project leadership, helping secure that project timelines are met with minimal technical risk.
Your main tasks will include
  • Establishing and refining user needs and product requirements through contextual, structural, and functional analysis
  • Interpreting and incorporating relevant regulatory requirements and product standards (e.g. ISO11608 and MDR) into the product requirements
  • Defining design solutions, and interface management
  • Participating in design reviews, and technical risk management
  • Facilitating trade-off decisions between technical domains
  • Planning and reporting of V&V and product integration activities
  • Ensuring traceability between design specifications and product requirements
  • Establishing design history file and submission file content
  • Change management and maintenance of technical documentation until production
  • Planning and coordination of system engineering activities
  • Providing mentoring towards supporting the development of more junior colleagues and improving internal processes
  • Qualifications
  • A Master’s degree or equivalent within engineering
  • At least a few years of experience and a proven track-record within systems engineering
  • Work experience within a regulated industry (e.g., medical devices, aerospace, transportation)
  • Professional proficiency within oral and written English
  • It would be considered an advantage if you have
  • Successfully taken a product from concept to production
  • Proficiency in digital requirements tools e.g., Magic Draw, Polarion or Modern Requirements
  • Experience with model-based systems engineering, product architecting, platforming, and/or product line engineering
  • Experience with MDR, ISO13485 and/or design controls
  • As a person, you are analytical, structured, and demonstrate attention to detail while remain good at keeping the bigger picture in mind. You thrive in a dynamic and changing environment and are not afraid of voicing your opinion and challenging status quo on internal processes. 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
    The Systems Engineering department consists of highly skilled and motivated professionals and specialists who take pride in being the experts driving system design, from early development to submission and production. We are part of Novo Nordisk Device Delivery Solutions, which is the organisation responsible for the development of device solutions for medical self-treatment within all business areas of Novo Nordisk A/S. In our department we have a wide range of development projects in different development phases that we contribute to, from connected devices to pens and auto-injectors, of which the vast majority need to be designed to accommodate production quantities of many millions per year. Our main aim is to further advance our offerings to people living with chronic diseases and their healthcare professionals through new technologies. You will join a dynamic, international, and innovative environment, where highly skilled professionals work closely together to develop next generation medical devices.
    Contact
    For further information or questions, please contact Christina Anne Storgaard +45 3079 9502. Deadline
    February 13th, 2023
    You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process.
    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.


    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 2.1.2023, men kan have været deaktiveret og genaktiveret igen.

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