Advanced Engineer for connected insulin devices

Advanced Engineer for connected insulin devices

• Research & Development
• Denmark - Hillerød

Do you aspire for development of the most innovative medical devices? Do you possess an overview of the regulations for hardware and software engineering for medical devices? Can you collaborate and work with internal and external stakeholders across research and development, production, quality and regulatory affairs? If yes, then we welcome your application to a key role in developing Novo Nordisk’s connected insulin devices.

Novo Nordisk Device R&D has a long and outstanding track record of developing the best, most innovative and widely used insulin devices in the world. We ensure that user insights, new innovations and regulatory requirements go hand in hand with a strong quality mind-set.

About the department
You will join a high performing team in Device R&D responsible for delivering Novo Nordisk’s first connected insulin device. We are an interdisciplinary group of hardware, software and mechanical engineers motivated by advancing the care of people living with diabetes. We deliver our results through great team spirit and collaboration. We are supported by Device R&D’s competence areas for test, innovation strategy and quality assurance. We work closely with colleagues across Novo Nordisk to coordinate production, marketing and regulatory plans. A number of development and production activities are outsourced. We have strong business relations and close technical collaboration with our outsourcing partner.

The position
As our new Advanced Engineer, you will be responsible for development tasks including planning and coordination with relevant stakeholders. Your tasks will for example include system engineering, requirement engineering, system verification and validation. You will work closely with our outsourcing partner for the technical development. For your tasks, you will be responsible for all phases from gathering input to approval.

Your working day will be dynamic with multiple tasks and many interactions to drive activities forward. Your success will be driven by your contribution to the execution of the project, the quality of your deliverables and your way of engaging with colleagues and stakeholders.

Qualifications
You hold a technical or scientific degree at Master’s Degree level or above and you have at least 3 years of experience with development of highly regulated products. You are well organised and have experience with Good Documentation Practice (GDP) within the medical device industry or related industries with similar regulations. You have experience with hardware development processes and software development processes. You have solid understanding and overview of medical device regulations or similar regulations. Preferably, you have experience with the Medical Device Directive, ISO 13485, FDA 21 CFR part 820, IEC 62304, or IEC 60601.

You are a strong team player recognised for your interpersonal skills. You are energetic and you are comfortable with taking initiative with a ‘can do’ mind-set. When solving problems, you combine theory and practise in a structured process and you are able to facilitate stakeholders. You communicate fluently in English both written and orally. Finally, you like to document your work.

Working at Novo Nordisk
At Novo Nordisk it is your skills, your commitment and your ambitions that help us improve the lives of many people. In return, we offer you the opportunity to work with highly committed colleagues. Moreover, the range of possibilities to develop both your professional and personal skills at Novo Nordisk is extraordinarily wide.

Contact
If you have any questions, please contact Rasmus Haahr at +45 3079 8955.

Deadline
20 August 2017.

Please write in your application that you've seen the job at Jobfinder