Design Validation and Usability Specialist

City: Ballerup Country/Region: Denmark, Germany State: Business Area: Clinical Research Department: Employment Type: Full-time Req ID: 10583 Do you want to help develop medical devices that improve patient care and save lives? At Ambu, the user is at the center of everything we do. As a Design Validation & Usability Specialist, you will play a key role in bringing the voice of the user into product development through usability engineering, design validation, and user-centered testing. Working closely with healthcare professionals and cross-functional project teams, you will plan and conduct usability studies, evaluate new product concepts and prototypes, and generate insights that directly influence product design and development. You will be assigned to projects within specific clinical areas, providing a unique opportunity to build in-depth clinical knowledge and understand the workflows, challenges, and needs of healthcare professionals. You will also gain hands-on experience with simulation manikins and realistic clinical scenarios, enabling you to evaluate products in environments that closely reflect real-world use. This is an exciting opportunity to combine technology, user understanding, and clinical insight while contributing to the development of innovative medical devices used by healthcare professionals around the world. What are we looking for? We are looking for a motivated and collaborative professional who thrives in a project-driven environment and enjoys planning, designing, and conducting design validation studies and usability engineering activities. As our ideal candidate, you:

• Have experience within usability engineering, human factors engineering, design validation, user research, or a related discipline, preferably within the medical device industry or another highly regulated environment.
• Have hands-on experience planning, moderating, and conducting usability studies and user evaluations.
• Are able to plan and execute usability engineering and design validation activities using established methods, processes, and templates.
• Have a structured and systematic approach to planning and executing tasks and can manage multiple activities, changing priorities, and project uncertainties while maintaining a high level of quality and attention to detail.
• Have strong analytical and problem-solving skills and can identify risks, gaps, uncertainties, and opportunities for improvement.
• Enjoy facilitating workshops and collaborating with cross-functional teams to understand user needs and generate meaningful insights.
• Can communicate findings, recommendations, and concerns clearly to project teams and stakeholders.
• Have excellent written and verbal communication skills in English and are comfortable working with international stakeholders and colleagues.
• Have strong technical writing skills and can create clear, structured, and high-quality documentation.
• Work independently within your area of responsibility while knowing when to seek alignment and escalate challenges.
• Take ownership of assigned tasks and consistently deliver high-quality results.
• Are a strong team player who shares knowledge openly, builds positive relationships, and contributes to a supportive team culture.
• Have the maturity and flexibility to navigate changing project priorities and evolving business needs.
• Clinical experience as a healthcare professional (e.g., nurse, physician, or similar) or through direct work in a clinical environment is considered a strong advantage.

Preferred Qualifications

• Degree in Human Factors, Psychology, Engineering, Biomedical Engineering, Medicine, Design, Nursing, or a related field.
• Knowledge of usability engineering and design controls for medical devices, including familiarity with standards and regulations such as IEC 62366-1, ISO 13485, MDR, or FDA guidance.
• Experience planning and conducting usability studies, user needs activities, design validation testing, or risk analysis activities.
• Experience working directly with healthcare professionals and understanding clinical workflows and user needs.

This role would suit someone who enjoys hands-on project work, values collaboration, and wants to further develop their expertise in usability engineering and design validation while contributing to the development of safe and effective medical devices. The Team You will join our Design Validation & Usability team, a global team of 15 specialists. Our common goal is to ensure the users' voice is integrated throughout product development and that Ambu's solutions are safe, effective, and intuitive for healthcare professionals around the world. The team is part of Ambu's Clinical Affairs organization and brings together expertise in design validation and usability engineering. We work closely with colleagues across R&D, UX, Regulatory Affairs, Quality, Marketing, and Clinical Affairs to ensure that user needs are translated into meaningful and safe product solutions and thoroughly validated throughout the development process. Our team is distributed across Ambu's headquarters in Ballerup, Denmark, and our Innovation Hub in Augsburg, Germany, creating a collaborative international environment with opportunities to work with colleagues across locations. Knowledge sharing and collaboration are central to how we work. We actively support one another, exchange experiences, and learn from each other's projects and clinical areas. The position can be based in either Augsburg, Germany, or Ballerup, Denmark, and reports to the Design Validation & Usability Manager. You should expect regular travel between our Danish and German sites, as well as travel related to user studies and testing activities, primarily in the United States and Great Britain. Ambu – a visionary and international workplace where your efforts matter 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 head 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. 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.