Platform Subject Matter Expert

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Hillerød

Do you want to take part in shaping the future of product development, and to help grow the organisation to cope better with complexity and a growing portfolio? If yes, apply for a life-changing ca-reer! We are seeking a highly skilled Platform Subject Matter Expert to join our newly established team, Platform Projects and Process Management.The position
As a Platform Subject Matter Expert, you will be pivotal in defining processes, leading process activities, and ensuring the successful development and deployment of our Medical Device Platforms. The ideal candidate will have extensive experience in medical device development and platform development.You will work closely with our Platform Process Manager and be responsible for defining and establishing processes and guidelines for how we develop platform solutions, while ensuring that these processes fit within our Quality Management System (QMS). Therefore, it is crucial that you are detail-oriented and excel in writing process descriptions, including facilitating meetings and coordinat-ing reviews with key stakeholders.Your main responsibilities will include:
  • Define, document, and continuously improve processes related to platform development for medical devices and delivery solutions
  • Lead and facilitate process activities, including writing and updating Standard Operating Procedures (SOPs) and guidance documents
  • Collaborate with cross-functional project teams to provide strategic direction and support for platform development initiatives
  • Ensure that all processes comply with relevant regulatory requirements and industry best practices
  • Conduct training sessions and workshops to enhance team capabilities and knowledge in platform development
  • Act as a knowledge resource for project teams, providing expert advice and guidance on technical challenges and opportunities
  • Monitor industry trends and advancements to incorporate innovative approaches in platform development
  • The portfolio of projects is not only expanding but also heading into new therapy areas as well as leveraging digital solutions. To meet these new challenges, we need to refine our capabilities and processes – also within Platform Development of Medical Devices. As a Platform Subject Matter Expert, with insights into the development processes of Platform Medical Devices, you will be an important contributor in shaping the future ways of working in Devices & Delivery Solutions.Qualifications
    To be successful in this role you have:
  • Bachelor’s and/or master’s degree in Engineering, Life Sciences, or a related field
  • A minimum of 5 years of experience in medical device platform development or a related area
  • Strong understanding of regulatory frameworks applicable to medical devices, including ISO standards
  • Experience in process improvement methodologies (e.g., Six Sigma, Lean)
  • Excellent communication, leadership, and interpersonal skills
  • Ability to work effectively in a collaborative team environment and manage multiple priorities
  • As a professional, you have a proactive outlook, enjoy new challenges, and are orientated to drive processes and meet deadlines. You have experience navigating in a complete stakeholder landscape and can analyse and understand complex structures and systems and use excellent communications skills when presenting this. Furthermore, this position, you are required to be fluent in oral and written English.About the department
    The Platform Development area consists of Programme Managers, Technical Project Managers, Project Managers and a Process Manager. We are responsible for driving Platform Medical Device Projects as a part of [xxxxx] Device Delivery Solutions, which is the organisation responsible for the development of device solutions for medical self-treatment within all business areas of [xxxxx] A/S. In our department, we have a wide range of development projects in different development phases, and you will join a team contributing to projects related to pens and auto-injectors.You will join a dynamic, international, and innovative environment, where highly skilled profession-als work closely together to develop next-generation medical devices.

    Working at [xxxxx]
    At [xxxxx], 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

    Contact
    For further information, please contact Trine Østergaard Olsbjerg, Senior Manager, at +[xxxxx].Deadline
    1 June 2025
    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 15.5.2025, 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.
    • Øvrige
    • Hillerød

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