• Job Description

  Req#: 287411

  Are you an ambitious System Engineer looking to work on advanced cell therapeutics providing technical leadership to product development teams for medical device combination products? If yes, apply today as this is the dream job for you!

  The position

  As a System Engineer, you will join our team that is responsible for the development of medical devices for cell therapy. You will be the technical lead ensuring the team designs, develops, tests, and documents innovative system solutions for various Cell Therapy applications. You will lead the definition and development of user needs, business needs, use cases, requirements, and system architecture. In addition, you will be responsible for leading the engineering analysis to optimize and select system-level concepts to ensure the final solution fulfils requirements and the overall system vision.

  Some of your responsibilities will include:

  • Developing and leading verification and validation activities to ensure that product designs meet the customer needs, including bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.
  • Preparing documentation to support Design Reviews at respective design control milestones.
  • Leading the team in generating the risk management file and identifying and mitigating technical risks, product hazards, and failure modes.
  • Providing technical leadership along technical and clinical procedures and being a subject matter expert to internal and multi-disciplinary development teams.
  • Exploring new technologies and examining the possibilities for diverse product solutions as well as influencing strategic direction around design practice and processes.
  • Supporting surgical procedure introduction of the design.
  • Supporting the planning and execution of user evaluations in lab-based surgical environments or other formative evaluation events to gain insightful feedback on system concepts.
  • Supporting design transfer to manufacturing and ensuring design for manufacturing implementation as part of the development process.

  Qualifications

  You have a bachelor’s degree in biomedical engineering, mechanical engineering, material engineering or any other related discipline and minimum 5+ years of experience in R&D medical devices. You have extensive experience in Product Development, specifically Design Control and Design Verification and Validation.

  To be successful in this role you possess:

  • Experience in working with external academic and industry partners.
  • Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations.
  • Familiarity with medical device standards (e.g. IEC 60601, ISO 10993, ISO 14971, IEC 62366).
  • Previous experience in cell therapy, drug combination products, or implantable products is a plus.
  • Technical leadership experience and strong report writing, drafting and documentation skills.
  • Detail and deadline oriented with critical thinking, and problem-solving skills.

  As a person, you are flexible and adaptable as the tasks are multiple, variable and the priority of projects may change and may range from specialist oriented to a more general character. You are ready to adjust your schedule leading to overtime when met with periods of increased workload. In addition, you have strong teamwork capabilities and interpersonal skills in dealing with colleagues and customers. Fluency in written and spoken English is required.

  About the department

  The Cell Therapy team is focused on developing cellular medicines that have the potential to change the way doctors treat intractable diseases. We manufacture targeted cell types derived from pluripotent stem cells using precisely controlled expansion and differentiation processes. Therapeutic areas of current focus include cardiomyocytes to treat heart failure, beta cells for diabetes, and dopaminergic neurons for Parkinson’s disease.

  Join a dynamic, innovative and interdisciplinary team focused on developing the medical devices and combination products that enable preparation and delivery of these novel cell products. With facilities in Copenhagen, Denmark and Fremont, California, we develop micro and macro fluidic formulation and cell product handling devices, as well as a broad range of administration applications including devices for stereotactic brain delivery, beating heart delivery, general surgical implantation, etc.

  Working at Novo Nordisk

  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 Novo Nordisk, 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 energise 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 please contact Kristian Kolind, Head of Cell Therapy Devices, site Denmark, at ktko@novonordisk.com or +45-30794374.

  Deadline

  31 January 2024.

  Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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 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.

• About the company

  Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries.

Notice