Lead Systems Engineer

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[xxxxx] is on an exciting journey: Developing Digital Therapeutics, Connected Health and Digital Health solutions of the future. These solutions are scoped for health care providers and patients living with different chronic diseases. Are you up for a challenge of driving development of Digital Health solutions? Then you might be the Systems Engineer we are looking for! The position As Lead Systems Engineer with DDS Companion SaMD solutions you will be acting as a technical steward combining Systems thinking and technical knowledge of physical and software components, best industry practices as well as regulatory requirements to create state-of-the-art frameworks for developing digital solutions. As an area specialist often included in cross-functional projects and/or often required to work internationally. You are often required to act as a dynamic negotiator in high-stake conversations to ensure the technical alignment with stakeholders/suppliers with a divergent interest to accept new concepts, best practices, and approaches. Furthermore, your main responsibilities will include:
  • Driving systems engineering activities in regulated software product development and ensuring that best practices (e.g., IEC 82304/62304, MDCG & FDA guidelines) are followed and implemented as appropriate for the software classification of a digital solution.
  • Ensuring design controls by capturing, defining, and managing user and product requirements, executing risk management activities, documenting design outputs, and planning and reporting design verification and design validation.
  • Acting as a Systems Engineering ambassador within the organization to increase overall systems engineering impact and systems thinking maturity.
  • Devising strategies for the development of digital products by bringing together all relevant stakeholders in the organization and enabling their effective collaboration.
  • Co-driving software development processes for emerging SaMD products.
  • Being the technical lead in one or more core product teams within [xxxxx] digital solutions and having the responsibility to ensure quality by design in the smartest possible way, taking standards, safety and security, best practices, business, and user needs into consideration.
    • This position may require occasional traveling domestically and internationally up to 10%. Qualifications To be considered for this position, we expect you to:
  • Hold a Master's or PhD degree in a relevant field, such as software engineering, electronic engineering, ICT engineering, medical device engineering, applied physics, etc., with a minimum of 5 years demonstrable and proven record in Systems Engineering.
  • Have worked in the development of safety-critical software systems in a regulated industry (e.g., IEC 82304, IEC 62304, ISO 14971, and ISO 13485, DO178B/C).
    • It would be great advantage if you have the following:
  • INCOSE Systems Engineering Professional (SEP) certification ASEP, and preferably CSEP.
  • Experience with Technical Project Management in regulated environment and experience with AI product development
  • Experience with software development principles mobile applications, and cloud-based services and tools (e.g. Agile development, Scrum, Jira, Jama, ADO, and Modern Requirements)
  • Experience with operating under Medical Devices Design Control and having knowledge of FDA 21 CFR 820, FDA Guidance for Content of Premarket Submissions for Device Software Functions
    • A successful candidate will demonstrate excellent communication, negotiation, and problem-solving skills, as well as an ability to bring clarity to complex situations. You should feel motivated by enabling data-driven decision-making in a complex stakeholder landscape. Value teamwork, be self-motivated, and capable of managing your work schedule and navigating through project milestones About the department In Device & Delivery Solution (DDS), we have more than 400 colleagues who design and develop innovative integrated delivery solutions, including connected systems and Software as a Medical Device (SAMD), to support the [xxxxx] drug portfolio. By ensuring feasible solutions, business value, and a focus on the end-user, we help people live a life with as few limitations as possible. That’s what we call empathy-driven innovation. SAMD supports integrated delivery solutions to fully enable patients to take the right dose, in the right way, at the right time, simplifying treatment and enabling a more meaningful dialogue between the patient and healthcare provider. This, in turn, means that patients are further supported in following their treatment regimen, leading to improved patient outcomes. To ensure this development journey, our delivery and connectivity systems are developed in close collaboration between patients and the scientific discovery teams across [xxxxx]. The DDS Companion SaMD Solutions organization comprises 50 employees located in Boston (US), Seattle (US), and Søborg (DK). You will be part of the team of competent project managers and engineers located in Søborg who engage in the development of the first-generation SaMD products within [xxxxx]. Working at [xxxxx] We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at [xxxxx], life means many things - from the building blocks of life that form the basis of ground-breaking scientific research to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease. Contact For further information related to the position, please contact Ramin Moshavegh, Acting Department Manager at +[xxxxx]or Irvin Mangwiza, Associate Director - SAMD Systems Engineering, at +[xxxxx]regarding any other questions. Deadline 14 April 2024. Please note that applications will be reviewed, and interviews will be scheduled on an ongoing basis. 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 to 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.


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    Jobbet er oprettet på vores service den 2.4.2024, men kan have været deaktiveret og genaktiveret igen.

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