Systems Engineer

Systems Engineer

Do you have experience developing medical devices? Would you like to be part of developing innovative products that make a meaningful difference to patients, while applying your skills in a global MedTech company that is helping shape the future of endoscopy?

Then your next career move could be as a Systems Engineer with Ambu.

Be a Key Player in Engineering & Imaging

In this exciting role, you will be a key contributor within our R&D organization and a leading technical member of a product development project. You will play a central role in shaping and delivering innovative endoscopy solutions, directly contributing to Ambu’s future success and to improved outcomes for patients and healthcare professionals.

As part of this position, you will join a team responsible for developing a go-to-market solution that introduces new product features AI capabilities to our existing portfolio of display units. This will enable us to gain valuable experience with AI-enabled solutions while preparing for the development of our next-generation display unit. The solution will support our current portfolio of endoscopy products while also laying the foundation for future platforms, capabilities, and product offerings.

You will be part of our Global Systems Engineering department and report to the Systems Engineering Team Manager. The position is based at our headquarter in Ballerup, Denmark, where you will join a collaborative, professional, and globally connected team.

We foster a strong culture of innovation, with a clear focus on fast time-to-market while remaining deeply committed to developing the right products to meet customer and user needs, ultimately improving patient care. This requires the ability to navigate complex medical device development and bring different technologies, disciplines, and perspectives together into coherent product solutions.

You will join a truly global Systems Engineering team of 22 highly skilled and motivated colleagues based across different locations. The team is part of Engineering & Imaging within our R&D organization and brings together a diverse mix of backgrounds, perspectives, and expertise. What really stands out is the team’s strong collaborative spirit and proven track record of successfully bringing Ambu’s innovative products to market, making it a great environment in which to learn, grow, and contribute.

Global, User-Driven Innovation: From Idea to Launch

As a Systems Engineer, you will hold the overall technical view of the product and help subject matter experts, project team members, and other stakeholders understand each other and work effectively together.

You will be leading technical alignment and discussions in the project team to find the right solution, helping drive and maintain the overall technical solution and ensuring coherence across the different technologies and disciplines involved. You will navigate technical trade-offs, facilitate decisions, and ensure that the product solution remains aligned with user needs, business objectives, regulatory requirements, and the overall system architecture.

You will create, facilitate, and review key product development documentation, including requirements, design inputs, design outputs, and technical reviews. You enjoy working in cross-functional project teams, finding pragmatic solutions to complex technical challenges, and ensuring an appropriate level of documentation and technical rigor.

You will be involved throughout the product development lifecycle, from early scope investigation and concept development through design, integration, verification and validation, and ultimately market launch.

We work in a hybrid setup, typically with minimum three days on-site in Ballerup, providing flexibility while maintaining strong team connections.

Your Responsibilities

• Define, plan, document, and technically manage product development activities within the project to ensure the product is delivered in accordance with the defined design objectives and development plan.
• Identify and understand stakeholder and user needs through engagement with key stakeholders and users.
• Analyze and decompose user needs, business needs, and system requirements into clear and actionable product and development requirements.
• Leading technical alignment and discussions with the Project Manager and relevant Line Managers.
• Ensure alignment with product and technology architectures and promote the appropriate reuse of existing design solutions across the R&D organization.
• Investigate and scope new product concepts and solutions within existing or new clinical areas, building on Ambu’s technologies and capabilities.
• Establish and maintain the overall technical overview of the product, including system interfaces, dependencies, and trade-offs between technologies and design solutions.
• Ensure development, documentation, verification, and testing activities are performed in accordance with applicable FDA, ISO, IEC, and internal quality requirements.

Your stakeholder base will be broad, and you will collaborate across Ambu’s global organization, with functions involved throughout product development, as well as externally with users, knowledge centers, technical partners, and suppliers.

Our production sites are located in Malaysia, China, the USA, and Mexico, and we collaborate with KOLs and development centers across Europe, Asia, and the US. Some travel should therefore be expected, approximately 20 days per year.

Suggested Candidate Profile

Setting you up for success is one of our cornerstones. We imagine that you are proactive, driven, committed, and comfortable taking responsibility and ownership. You are thorough and quality-minded, with strong interpersonal skills and good situational awareness, enabling you to work effectively in cross-functional and global teams.

Skills and experience can be gained in many different ways, and we understand that the best fit for a role cannot always be defined on paper. That said, you are likely to thrive in this role if you bring:

• A degree or professional background in electrical engineering, mechatronics, mechanical engineering, biomedical engineering, or a similar technical field, together with relevant hands-on product development experience.
• Experience developing medical devices, including working with design control and requirements in a regulated environment, or comparable experience from another highly regulated industry.
• Experience in cross-functional product development involving hardware, electronics, mechanics, and software, ideally within medical devices or a related engineering or consultancy environment.
• A strong systems engineering mindset combined with a practical approach to developing robust and reliable product solutions.
• The ability to work independently, take ownership, and remain pragmatic and solution-oriented while actively sharing knowledge and collaborating within a global team.
• Experience working with an OEM, contract manufacturer, or external development partner would be an advantage.
• A solid understanding of relevant standards for medical electrical equipment, such as IEC 60601-1, IEC 60601-2-18, and ISO 80601-2-18, and experience translating regulatory and standards requirements into practical product development activities would also be an advantage

As Ambu is a global company, it is important that you communicate fluently in English. Only applications submitted in English will be considered.

How to Apply

We invite candidates for interviews on a continuous basis, so please do not hesitate to apply via our career site at ambu.com.

For additional information about the position and Ambu, please contact Team Manager, Systems Engineering, Engineering & Imaging, Jesper Bartroff Frederiksen, at [email protected]

Your application will be treated confidentially.