Release Engineer

Are you ready 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?

Then this might be your defining moment. In this exciting position, you will be an active contributor shaping the future of Ambu’s Endoscopy Systems.

Apply today and join us for a career where you will make the difference.

Shaping the future of Endoscopy Systems

Endoscopy Systems monitors and processing units to which our endoscopes are connected to show the live image. The Ambu software on the Endoscopy System then allows the health care professionals to adjust the image, take pictures and videos among many other functionalities.

You will take part in developing and maintaining our Endoscopy Systems to our end users' benefit and secure the future success of Ambu. 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, and a flair for design control, then there is a good chance that Ambu will be the perfect place for you to work!

In the position as Release Engineer, 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 tasks & responsibilities

• Driving the development, technical maturation, implementation, and building the documentation of new software features for our Endoscopy Systems in close collaboration with Project Managers, Product Managers and Product Owners.
• Analyzing system risks, customer needs, business needs, driving requirements definition and traceability, while securing the integration of our software and electronics platforms.
• Establishing and maintaining technical and documentation overview incl. system compatibility, interface management and integration of new technologies.
• Handle life cycle management activities including product updates to launched systems, accessories, and spare parts.
• Secure continues control and execution of NCRs and CAPAs of marketed Endoscopy Systems.
• Establishing, optimizing, and maintaining internal processes, procedures and templates that prescribe Ambu’s way of working in accordance with ISO and FDA requirements and guidelines.
• Secure that the product and system specific documentation follows Ambu QMS and meet the demands for FDA and MDR submissions.
• Working, documenting, and testing according to FDA and ISO requirements.

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, so some travel is to be expected with this position.

Setting you up for success is one of our cornerstones. In order to do so, we imagine you as a person with strong analytical and problem-solving skills with attention to detail and a proactive mindset. We are looking for a candidate with the following qualifications:

• Educational background within engineering, preferably within Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
• Experience with product development and/or product maintenance within the medical device domain, or similar regulated industry.
• Interest in /experience with IEC 62304, IEC 60601 and FDA guidelines for medical device software and electrical medical equipment.
• Practical application of regulations and standards to guide agile, iterative product development through design controls and risk management.
• Proven experience in working with minimum one of the following: 1) systems integration, 2) configuration, 3) risks and requirements, or 4) documentation in regulated industry.
• Proficiency in software systems engineering and quality assurance policy and procedure development, ensuring quality and patient safety in complex hardware/software systems.
• Team player with demonstrated ability to collaborate with global, cross-functional teams in a fast-paced environment, communicate clearly, and ensure stakeholder alignment.

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

Join the team!

We are a multinational medical technology company and the market leader in single-use endoscopy. From development and manufacturing to distribution and sale, we oversee the entire product lifecycle for our healthcare solutions across the fields of single-use endoscopy, anaesthesia and patient monitoring. Today, more than 100 million patients worldwide depend on the efficiency, safety and performance of our innovative solutions.

At Ambu, we have an innovative culture with a clear customer-centric focus – we are dedicated to developing high-quality products that fulfill customer needs and positively impact patients’ lives. We value excellent collaboration both internal and external to our business and the ability to keep the overview while going into the very detail be it technical subjects, process alignment/improvement or a new regulatory enforcement coming into play. You will join a growing team currently consisting of 6 passionate and highly engaged engineering professionals striving to reach ambitious goals while having fun and achieving together.

We will invite candidates for interviews on a continuous basis so don't hesitate to apply.

Your application will be treated confidentially.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.