Senior Systems Engineer to drive alternative drug delivery technology projects
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Hillerød
- Engineering
- Hillerød
Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transforming the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join the Novo Nordisk Device R&D organisation. Together we can create life-changing innovation. Together we can make it happen.
About the department
In the Alternative Delivery Technology department, our work resides in the intersection between medical device engineering and drug discovery and research. A core focus lies within alternative drug delivery technologies that can alleviate the need for frequent injections for patients within Novo Nordisk’s core therapeutic disease areas. Examples of technologies in scope include oral devices, implants, and transdermal patches. Our team is passionate about the discovery and development of medical devices, and we comprise a diverse mix of competencies spanning across multiple natural sciences and engineering disciplines. We work together with both industry and academic partners as well as with several areas of Novo Nordisk Drug Research and Development, such as formulation science, pharmacology, non-clinical development, and more. The scope of our activities spans from early technology discovery to device development for clinical trials. The medical devices being developing are a first for Novo Nordisk and the department heavily involved with the development of design control processes and Quality Management System for these new device categories.
The position
As our new Senior Systems Engineer, your primary responsibility lies within design control activities for novel device concepts from early research to First Human Dose. As such, you will be responsible for driving the process of defining and verifying requirements and together with the project manager ensure documentation is prepared for regulatory filing. The projects in the department are typically early research activities approaching phase 1 clinical trials and you will be operating across the value chain, working both closely with the engineering team within the department as well as with stakeholders in areas such as, e.g., Regulatory Affairs, Quality Assurance, Medical & Science, CMC, and Clinical Pharmacology. For this role, we expect you to combine your technical project knowledge with your great understanding of the regulatory pathway of medical devices to set direction for the concept development in the projects. You will use your strong communication skills to create clarity out of complexity for a multidisciplinary team of specialists within different subject matters. This role also relies heavily on your ability to build relations and to collaborate effectively with diverse stakeholders both internally and externally, including R&D partners from both academia and industry.
Qualifications
You are an expert within System Engineering, and we imagine that you have around 5 years of industry experience, ideally within class III medical devices and/or combination products. You have solid experience working with risk management preferably in the context of medical devices and you hold a MSc degree and have relevant experience within engineering or another related field. It is considered an advantage if you have experience in working with external vendors and/or contract manufacturing organisations (CMOs) in a pharmaceutical context or have experience with establishment and/or development of quality management systems, specifically with Design Control elements.
As a person, you are known for your strong communication skills that allows you to collaborate across technical disciplines and with various stakeholder landscapes. You are proficient in both oral and written English and you have a cooperative mind-set.
Working for Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Peter Herskind at +45 30757982.
Deadline
Deadline for applications is 15th of March, 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 26.11.2019, 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.
- Afdelingsleder
- Hillerød
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