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Software Process Owner, Software & Electronics City: Ballerup, Denmark; Augsburg, Germany State: Country: Germany Business Area: R&D Department: Endoscopy Systems Release Employment Type: Full-time

Do you aspire to play an important part in the fascinating future of software and artificial intelligence in the medical device industry? Are you passionate about creating procedures that enable and guide our developers to deliver innovative solutions to help patients worldwide? Do you on learning new topics and collaborating with stakeholders and subject matter experts to influence and define our ways of working?

Then your next career move may be as an Software Process Owner with Ambu!

Shaping the future of Endoscopy Systems

An endoscopy system is a monitor to which an endoscope is connected to examine the interior of a body organ or cavity. The endoscope is a long, thin tube with a light and camera at the end, inserted into the body through a natural opening or a small incision. This allows healthcare providers to view internal structures on the endoscopy system and adjust the image, take pictures, and record video,s among many other functionalities.

We are a diverse team of experienced professionals who ensure that new software and compatible endoscopes are released on the endoscopy systems while remaining safety and efficiency. Our team is called the Endoscopy Systems Release Team, and your title will be Software Process Owner.

You will work within the domains of Artificial Intelligence, Software as a Medical Device (IEC 82304-1), and Software Lifecycle Processes (IEC 62304). Your responsibilities will include updating existing procedures and creating new ones within these areas.

You will collaborate with subject matter experts to guide them in documenting their development work and work closely with the Innovation Process Solution team to ensure our procedures align with our Quality Management System (QMS).

This position can be based in either Ballerup, Denmark orAugsburg, Germany.

Key responsibilities

• Develop and write new standard operating procedures (SOPs) that describe the development of artificial intelligence in medical device software
• Improve Ambu’s existing software development procedures (IEC 62304)so they meet the current state of the art as well as recent FDA guidelines and feedback
• Develop and write new SOPs related to Software as a Medical Device (IEC 82304)
• Ensure adherence to regulatory requirements and industry best practices while making the processes practical and well-integrated with the rest of R&D processes
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs to gather necessary information and ensure accuracy and completeness of documentation
• Conduct regular reviews and updates of SOPs and quality handbooks to ensure they remain current and compliant with evolving standards and regulations
• Provide training and support to staff on the implementation and use of SOPs and quality handbooks
• Contribute to design control documentation for ongoing projects and already released products (e.g., Design Change Requests, CAPAs, and NCRs)

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Have a Master’s degree in a relevant field such as Biomedical Engineering, Computer Science, or a related discipline
• Have experience in software development and design control in the Medical Device industry
• Posses a comprehensive understanding of the regulatory and quality requirements when developing software for a medical device, including Software as a Medical Device and ideally AI functionality
• Have a mindset for quality, efficiency, and optimization, and thrives with structure and rules
• Enjoy reading and writing and can understand complex material
• Are interested in utilizing AI tools (e.g., Microsoft Copilot) in your daily work for writing procedures, running meetings, making plans, and general documentation
• Have excellent written and verbal communication skills in English
• Knowledge of ISO 62304 and ISO 13485 would be an advantage

When to apply

As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a leading multinational medical device company dedicated to improving patient care through innovative solutions. With a strong focus on research and development, Ambu designs and manufactures high-quality medical devices that enhance the efficiency and effectiveness of healthcare professionals. Today, more than 100 million patients worldwide depend on the efficiency, safety and performance of our innovative solutions, and we are committed to maintaining the highest standards of quality and compliance

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

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.

For more information, please visit ambu.com or follow us on LinkedIn .

Apply now

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