Product Development Engineer Risk Management (2year Temporary Paternity Cover)

Do you have handson experience with risk management in a regulated environment and want to play a key role in developing patientcentric drugdevice combination solutions Join us in a 2year temporary paternity cover where you will take ownership of risk management activities across both development and maintenance of products.

Your new role

In this temporary role you will act as a safety risk manager taking ownership of endtoend risk management for manual prefilled syringe products. You will collaborate closely with crossfunctional partners to ensure robust documentation regulatory compliance and highquality decisionmaking throughout the product lifecycle.

Your key responsibilities include:

• Leading planning execution and documentation of risk management activities throughout the product lifecycle
• Supporting design control with a structured riskbased approach
• Facilitating risk assessments with internal and external stakeholders
• Securing highquality timely documentation and clear communication across functions
• Contributing to improvements in processes tools and risk management methods

Your new department

You will join the Manual Prefilled Syringes team a group of around seven dedicated colleagues within a department of approximately 25 people. The team works with development and maintenance of combinationproduct device solutions ensuring safe reliable and userfriendly outcomes.

You will be part of a collaborative supportive environment where ownership structure and proactive communication are highly valued.

Your skills and qualifications

We imagine that you bring strong practical experience and can quickly adapt to a regulated crossfunctional environment.

We are looking for someone with:

• A relevant academic degree within engineering biomedical sciences or similar.
• Extensive handson experience with risk management ideally from medical devices or another regulated industry
• Familiarity with ISO 14971 and ISO 13485
• Experience with drugdevice combination products is a strong plus

• Experience within FDA 21 CFR 820 and EU MDR is considered a strong plus

• The ability to work independently manage multiple priorities and drive solutions with a proactive mindset

On a personal level you communicate clearly and confidently with internal and external stakeholders. You are comfortable operating in uncertain or evolving environments and maintain structure even when priorities shift. You collaborate naturally across disciplines build strong relationships and bring an agile solutionoriented mindset.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with determination constant curiosity and a commitment to finding better ways forward. For over 100 years this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking shared purpose and mutual respect come together to create extraordinary results. When you join us youre not just starting a job youre becoming part of a story that spans generations.

What we offer

There is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.

Contact: For further information about the position please contact Stasys Montvydas at 45- or Bjarke Dupont Jørgensen at 45-.

Application Deadline: 12th April

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.