Clinical Engineer - Usability Engineering
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If you are an ambitious Clinical Engineer looking to advance novel cell/device combination products and are looking to act as a primary interface with clinicians for design, development, testing and implementation of medical devices, then this is the dream job for you!Sounds interesting? Then read more and apply, as you might be our new Clinical Engineer. The positionAs Clinical Engineer you will join our team responsible for development of medical devices for cell therapy.You will be responsible for: Advancing medical devices from conceptualization through to commercialization using knowledge of Design Control processes (compliant with: MDR, ISO 13485, QSR / 21 CFR Part 820, etc) throughout Working with clinical staff (surgeons, nursing staff, clinical coordinators) to collect and synthesize customer inputs to support the definition and development of user needs, business needs, use cases (workflow) and other requirements Supporting the planning and execution of user (usability) evaluations via lab-based surgical environments or other formative evaluation events to gain insightful feedback on system concepts Developing pre-clinical models and test methods to support medical device feasibility, usability, and validation testing Supporting risk management activities by providing clinical risk assessments in various documents including Risk Analyses, Failure Modes and Effects Analyses, Fault Trees, Fishbone Diagrams and similar risk assessment and management tools Becoming the subject matter expert on the use of the designed medical device (system) and leveraging this to provide both training to clinical staff and support for initial clinical cases
QualificationsA 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 thrive and succeed, we expect you to have: Strong technical, human factors engineering/usability, critical thinking, communication, problem-solving, and interpersonal (teamwork) skills Development of class II or class III medical devices across all phases Track record of developing clinical procedures for novel medical devices, enabling successful clinical implementation Thorough understanding of risk assessment, management and mitigation strategies, tools and techniques to ensure positive risk/benefit determinations. Experience with operating suites, operating room procedures and personnel, standard surgical and interventional equipment and disposables, and sterile field management Managing collaborations, contracts and partnerships with external industry groups. Demonstrated success managing clinical partners 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. About the departmentThe 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 NordiskWe 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. ContactFor further information, you can contact Josh Godfrey at [email protected]. Deadline28 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 – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process. 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.
QualificationsA 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 thrive and succeed, we expect you to have:
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Jobbet er oprettet på vores service den 2.1.2024, 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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