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.

Are you an experience Usability and Design Validation Specialist eager to expand your clinical and technological expertise?

A job with global impact - saving lives and improving patient care

At Ambu, we are dedicated to advancing medical technology through innovative design and rigorous usability testing. As a Senior Usability and Design Validation Specialist, you will play a pivotal role in shaping the future of our products. We include users in product development, and you will be a front-runner for this, conducting formative usability tests and evaluations to ensure our products meet the highest standards of user experience and safety. Your insights will directly influence design decisions, making a tangible impact on the final product. You will work closely with Ambu User Experience Researchers to analyze user journeys and tasks. This collaboration ensures that our products are not only safe and functional but also intuitive and user-friendly.

This role can be based in either our HQ in Ballerup, Denmark or our R&D Site in Augsburg, Germany. We have amazing colleagues on both sites!

The Team

You will join a global department of 11 experts in Design Validation and Usability – with one common goal: Improving patient care and saving lives. The team is distributed between headquarters in Ballerup, Denmark and Ambu Innovation hub in Augsburg, Germany. Expect some travel between the sites.

Key responsibilities

• Apply Usability Engineering throughout the product lifecycle according to IEC 62366-1
• Perform Design Validation to ensure compliance with MDR, ISO 13485:2016 regulations and FDA 21 CFR guidance
• Serve as primary contact for Usability and Design Validation inquiries and decisions within your assigned projects
• Contribute to defining User Needs to ensure they are validatable
• Lead the use-error risk analysis activities and support the risk management process by contributing to Product Risk Evaluation with knowledge of use errors and clinical use
• Plan and execute formative evaluations, design validation, and summative usability studies with intended users
• Identify simulation manikins suitable for product evaluation
• Author and contribute to the Usability Engineering File, Design Validation, and documentation for regulatory submissions

Setting you up for success is one of our cornerstones. In order to do so, we imagine you are proactive, with high drive, commitment and have a strong sense of responsibility for your own tasks. You are thorough and quality-minded; you have great interpersonal skills and good situational awareness, making you a great team player in global teams.

Furthermore, you bring:

• 5+ years of proven experience within usability engineering for medical devices and have a thorough understanding of design control
• Experience working with identifying and defining use introduced risks and product requirements on different levels
• A technical interest with a patient-centric mindset
• An interest in anatomy and physiology, and clinical knowledge will be an advantage
• Strong communication skills and knowledge about its impact in both communication with users and colleagues

On a personal note, you can work independently and take responsibility for your own tasks. You have a pragmatic and practical approach to assignments. You actively support knowledge sharing and exploitation of best practice, and you enjoy being part of a global team. As Ambu is a global company, it is important that you communicate fluently in English.

Only applications received in English will be considered.

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international office with an informal working environment.

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.