Systems-Engineer%2C-Software-and-Electronics

Do you want to apply your skills in a global MedTech company currently disrupting the endoscopy market? Would you like to be a part of developing innovative products that significantly impact patients' lives? Are you ready to take systems engineering at Ambu to the next level?

Then this might be your defining moment. In this exciting position, you will be an active contributor to R&D as a Systems Engineer. Apply today and join us for a career #ForeverForward!

A role impacting millions of lives

You will take part in developing features for our display unit products and secure the future success of Ambu and to our end users' benefit. If you know what it takes to work with systems and integration across technologies and have a passion for securing fast introduction of new technologies to the market, then there is a good chance that Ambu will be the perfect place for you to work!

In this System Engineer position, you will be involved in all phases of the product development process – from the conceptual design to the product validation and all the way to product sustaining and handling of design changes.

It is expected that you can work independently and show strong skills in organizing and structuring the work, following up on internal and external stakeholders to secure progress according to plan.

You will play a key role in our projects, where you will create product documentation such as requirements, design outputs, submission documentation etc. Further so, you will take part in defining new features for our users, also securing our internal processes are up to date to support new technologies implemented in our products. You enjoy working in project teams and can identify pragmatic solutions to technical issues along with promoting the right level of documentation towards stakeholders.

Key responsibilities

• Establishing, maintaining, and controlling Project documentation.
• Drive implementation and documentation of new features in Displaying Unit Products.
• Secure NCRs, and CAPAs handling for our marketed Displaying Units.

• Involvement in process updates and optimizations so our procedures are efficient and in line with authority requirements.
• Working, documenting, and testing according to FDA and ISO requirements.
• Overall secure together with cross functional stakeholders that the document set for the specific product and system follows Ambu procedures and meet the expectations for FDA and MDR submissions.

Your contact base is broad, and you will collaborate with Ambu’s global organization, all departments involved in product development projects and external technical partners and suppliers.

Discover the force of our culture

At our headquarters in Ballerup, where we develop many of our new medical devices, we have a great innovation culture and a clear focus on fast time to market. We are dedicated to developing the right product to fulfill customer/user needs and positively impact patients’ lives. This sets high demands for your understanding of developing medical devices and the integration into complex systems.

You will report to the Systems Engineering Manager, Software & Electronics and join a team of 4 passionate and highly engaged engineering professionals who #TakeCharge and #TeamUp to make impactful results.

You are an experienced medical device engineer

Setting you up for success is one of our cornerstones. In order to achieve this; we imagine you have:

• A background as an engineer, and knows what it takes to make high quality products
• Proven experience in working with systems engineering, e.g. integration, configuration, requirements, and documentation under design control
• Knowledge within standards for medical devices.
• Interest in and experience with IEC 62304.
• Excellent communication and collaboration skills

• Team player skills, with a structured and analytical approach. Working proactively with prioritizing, planning, and finalizing task.

As Ambu is a global company, it is important that you communicate fluently in English

How to apply

We will invite candidates for interviews on a continuous basis so no need to hesitate to apply.

You can get additional information about the job and about Ambu by contacting Systems Engineering Manager, Software & Electronics – Mathilde Granberg on +45 7225 2000

Your application will be treated confidentially.