Development R&D Engineer
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Are you an ambitious Development R&D engineer looking to work on advanced cell therapeutics providing technical leadership to product development teams for medical device and cell/device combination products, then this is the dream job for you. We are searching for two Engineers to join our team. Apply today! The position As a Development R&D Engineer, you will join our team responsible for the development of medical devices for cell therapy. You will be responsible for: Leading device development activities in support of cross-functional teams to prepare medical devices for various Cell Therapy applications Driving the planning, execution, and reporting of risk management activities including risk management planning, the Preliminary Hazard Analysis (PHA) and identification of hazards, the System Risk Analysis (SRA), the User and Design FMEA (uFMEA and dFMEA) and identification of Risk Control Measures (RCMs) Driving planning, execution, and reporting of laboratory tests from early feasibility to verification Prepare documentation to support establishing the technical file for the medical device/combination product Exploring new technologies, examining the possibilities for diverse product solutions
Qualifications A Bachelor's degree is required, preferably in a relevant engineering field, with a preference for candidates holding a Master's degree. Additionally, candidates should have 4+ years of relevant experience with a Bachelor's degree or 3+ years of relevant experience with a Master's degree. To be successful in this role you need to have experience: In Product Development, specifically Design Control and Design Verification & Validation In performing risk analysis for medical devices 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) In tests and measurements, including test method development as well as proficiency in technical report writing, drafting, and documentation Previous experience in cell therapy, drug combination products, or implantable products is a plus Working with external academic and industry partners As a person, you are flexible and adaptable as the tasks are multiple, and the priority of projects may change and may range from specialist-oriented to a more general character. 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 you can contact Kristian Kolind on [email protected]. Deadline 14 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.
Qualifications A Bachelor's degree is required, preferably in a relevant engineering field, with a preference for candidates holding a Master's degree. Additionally, candidates should have 4+ years of relevant experience with a Bachelor's degree or 3+ years of relevant experience with a Master's degree. To be successful in this role you need to have experience:
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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 19.12.2023, 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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