Systems Engineer - Medical Packaging Development

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Do you have an interest in medical and pharmaceutical packaging and regulatory documentation? Are you ready to develop and ensure regulatory standards and requirements in our development projects? Are you thriving in a global and diverse environment while collaborating with a variety of cross-functional stakeholders?

Then, this is your chance. Apply now and join our Secondary Packaging Development Team as Systems Engineer. Together we are life-changing.

The position
In the Secondary Packaging Development Team, we are responsible for all development projects within medical and pharmaceutical products within Novo Nordisk. We design, develop, and ensure regulatory approval of our secondary packaging items.
We are establishing a new role as systems engineer to support our growing portfolio and to provide lean and compliant documentation within our area. As a Systems Engineer, you will play a vital role in our development projects where you will be responsible for all technical documentation that must be established during a development project.
This entails close collaboration with our development engineers, secondary packaging leads, device system engineers, and test engineers to support the timelines for the overall project.
Additionally, you will lead alignment activities with stakeholders across Novo Nordisk, from production, marketing, regulatory affairs, and strategic sourcing to establish the necessary regulatory documentation.

Your main responsibilities:
  • Function as a functional and technical lead for secondary packaging in project discussion(s)
  • Analyze and maintain regulatory requirements for secondary packaging; and support our development engineer(s) with requirements for the design of the product
  • Represent secondary packaging in cross-organizational discussions
  • Create and maintain overview of secondary packaging module configuration(s) and its technical documentation
  • Establish and maintain regulatory documentation for our development projects until transfer to production
  • Set up future design verification test strategies for our development projects

  • Qualifications To thrive and succeed, we expect you to have:
  • You have a master’s degree in engineering or similar
  • At least 2 years of experience with requirements engineering and/or technical documentation for product development, preferably within the medical device or pharmaceutical industry
  • Proven track creating regulatory documentation for authorities and our stakeholders
  • Experience with design control(s) (21 CFR 820.30 and ISO13485)
  • It is an advantage if you have experience with packaging materials
  • Proficient in written and spoken English

  • As a person, you are detail-oriented and self-driven with an analytical and systematic mindset. You have good interpersonal and communication skills, and a collaborative attitude. Overall, you are used to working in a global setting with a complex stakeholder landscape. About the department
    The Secondary Packaging Development Team develops the specifications of non-printed packaging material and is responsible for the overall planning of related activities and input needed to deliver fully developed packaging material in alignment with Novo Nordisk timelines. We ensure manufacturability of the design in collaboration with suppliers and production, and we strive for developing robust and sustainable solutions. We support numerous projects with different expertise, as such, tasks lying outside the above description can also be expected. You will join a cross-functional area with dedicated and highly competent colleagues in an area responsible for developing secondary packaging and user communication (IFU and user instructions).

    Working at Novo Nordisk
    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 letting perfection standing in the way of good. 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 you can contact Ole Christian Madsen, Head of Secondary Packaging Development, +45 3075 2257 or Signe Søndergaard Jeppesen, Process Manager, +45 3075 6975.

    Deadline
    15 November 2023. Applications will be reviewed on a running basis, so don’t hesitate to apply as soon as possible.

    To ensure a fair and efficient recruitment process, please refrain from adding a photo to your CV or resume. 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 30.8.2023, 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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