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

Join Ambu to make a meaningful impact on patient care and enhance the daily experiences of our users. 

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. Your expertise will help bridge the gap between user needs and product design. Ambu products are used in many different clinical specialties and environments. You will be allocated to a project within a specific clinical area, allowing you to gain in-depth knowledge of that specialty. You will also have the opportunity to deep-dive into the world of simulation manikins, which are crucial for replicating clinical scenarios. This hands-on experience will enhance your understanding and enable you to contribute more effectively to product development.

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. Collaboration and knowledge sharing are central, giving you ample opportunities to contribute with your expertise and engage in discussions about usability and design validation processes and methods.  

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  

• Collaborate with stakeholders in Malaysia, Germany and Denmark within your assigned development projects  

• Mentor Usability and Design Validation colleagues and facilitate process development workshops  

• Ensure compliance with the regulatory framework for medical device development and, particularly, IEC 62366-1 Application of Usability engineering to medical devices 

Suggested candidate profile 

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.   

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.