System Engineer - Design Control

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

Hillerød

Are you passionate about design control and eager to take ownership of some of the largest drug delivery systems on the market? If you have expertise in compliance, documentation, and system engineering and are ready to make a real impact in the medical device industry, this is your opportunity. Due to an increasing portfolio, we are looking for a new System Engineer to join our Cartridge-based device Team in Device Development. If you want to use your strong skills within design control and stakeholder management to take up responsibility for some of the largest products on the market, this is the position you are looking for! Join us on our journey to shape the future of drug delivery systems—apply today! The Position As a System Engineer in Device Development, you will have the responsibility for one or more of our medical devices/combination products and delivery system platforms and the belonging design control documentation. Your primary tasks include:
  • Driving the work in the post-launch phase of our products, striking the right balance between regulatory and internal requirements, as well as ensuring effective problem-solving in collaboration with a wide range of stakeholders.
  • Identifying, initiating, coordinating, simplifying, and executing device documentation initiatives e.g., mechanical design, requirements engineering, design verification, safety risk management, and submission support.
  • Contributing to the continuous improvement of everyday work in collaboration with the team; suggesting process improvement initiatives and helping to implement them.
  • Sharing your great design control expertise.
    • Qualifications On a personal level, you have strong networking and stakeholder management skills, allowing you to set direction, drive performance, and ensure quality in complex environments. You thrive as a key decision-maker for product-related matters and work effectively both independently and in collaborative projects. With a structured and solution-oriented approach, you take ownership and leverage colleagues’ expertise for optimal results. You value knowledge sharing and maintain a can-do attitude and sense of humor, even under pressure. To be considered for this position, we expect you to:
  • Hold a master’s degree in engineering, biomechanics, science, manufacturing, or any other relevant field.
  • Have around 5 years of experience working with compliance and documentation obtained within a regulated industry (medical devices, pharmaceutical, food, aviation, automotive).
  • You must have experience with the Design Control process.
  • Be fluent in English, both spoken and written.
  • Possess the ability to manage and drive several tasks simultaneously and take a methodical approach to your work.
    • About the Department Device Development (DD), part of Finished Product MSAT (Manufacturing Science & Technology), holds the design responsibility for [xxxxx]’s medical devices and delivery systems and is the link between Development and Production. In Device Development, the main task is to drive the introduction of new [xxxxx] products into the market while we maintain and continue the development of variants on our marketed device and product platforms. Our deliverables are directly impacting our capability to deliver to markets, enter new markets, and stay in the market. You will be joining the Cartridge & Needle Department, which consists of 25+ design control specialists and mechanical engineers. The Department holds the responsibility for all marketed cartridge-based devices and Needles. You can look forward to an exciting job with multiple stakeholders at a global and local level. Working at [xxxxx] At [xxxxx], we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care. Contact For further information about the position please contact Malene Fugl Andersen, [xxxxx] Deadline 4 April 2025. Applications are reviewed on an ongoing basis, so to maximize your chances, kindly submit your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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 [xxxxx] 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 19.3.2025, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 19.03.2025
    • Øvrige
    • Hillerød
    Rapportér

    Lignende jobs

    • Advanced Process Engineer

      Do you dream about working at the very core of the business, where you can make real impact daily? Would you like to bring your technical knowledge, a process-oriented way of thinking, a can-do att..
      • Øvrige
      • Hillerød
      Få mere info

    • Senior QA Professional for small molecules

      Are you passionate about setting direction within emerging technologies and ensuring compliance? Do you have experience within small molecules? Are you skilled in navigating complex stakeholder lan..
      • Øvrige
      • Nordsjælland
      Få mere info

    • Cleaning Process Supporter

      Are you curious about cleaning monitoring and validation during GMP production in a factory where changing between multiple products is our new reality? Are you ready to come on board and be part o..
      • Øvrige
      • Hillerød
      Få mere info

    • Process Supporter for API Production Processes

      Are you curious about a dynamic role where you'll drive innovation in API production? We are seeking two process supporters to join our innovative team in Hillerød – one focusing on purification pr..
      • Øvrige
      • Hillerød
      Få mere info

    Statistik over udbudte jobs som øvrige i Hillerød

    Herunder ser du udviklingen i udbudte øvrige i Hillerød over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.

    Se flere statistikker her:
    Statistik over udbudte jobs som øvrige i Hillerød over tid

    Dato Alle jobs som øvrige
    14. april 2025 62
    13. april 2025 73
    12. april 2025 73
    11. april 2025 72
    10. april 2025 67
    9. april 2025 72
    8. april 2025 71
    7. april 2025 70
    6. april 2025 79
    5. april 2025 79
    4. april 2025 81
    3. april 2025 74
    2. april 2025 75
    1. april 2025 75
    31. marts 2025 72
    30. marts 2025 74
    29. marts 2025 74
    28. marts 2025 68
    27. marts 2025 70
    26. marts 2025 68
    25. marts 2025 66
    24. marts 2025 65
    23. marts 2025 77
    22. marts 2025 77
    21. marts 2025 77
    20. marts 2025 77
    19. marts 2025 77
    18. marts 2025 73
    17. marts 2025 68
    16. marts 2025 74
    15. marts 2025 75
    Fold ud

    Populære søgninger

    Lignende søgeresultater

    Se alle populære søgninger