Are you a seasoned Senior Usability and Design Validation Specialist eager to expand your clinical and technological expertise? Join us to make a meaningful impact on patient care and enhance the daily experiences of our users.
Do you have a passion for testing medical devices with users? We offer a dynamic and challenging position where you will help ensure our ongoing commitment to delivering high-quality products. As part of our fast-paced innovation culture, you'll see a direct connection between your contributions and Ambu's growth, with a tradition of rapidly completing projects. This role can be based in either our HQ in Ballerup, Denmark or our R&D Site in Augsburg, Germany. We have amazing colleagues in both sites!
A job with global impact - saving lives and improving patient care
As a Senior Usability and Design Validation Specialist, you’ll play a pivotal role in ensuring our life cycle products are safe, effective, and meet user needs. You will plan and execute usability and design validation activities worldwide, working closely with stakeholders to save lives and improve patient outcomes.
Key responsibilities
- Apply Usability Engineering throughout the product lifecycle according to IEC 62366-1
- Perform Design Validation to ensure compliance with MDSAP, MDR, ISO 13485:2006 regulations, and FDA 21 CFR guidance
- Serve as primary contact for Usability and/or 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
- 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
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 pragmatic approach to balancing requirements and addressing challenges – all the while remaining autonomous and keeping your eyes on the ball.
Furthermore, you bring:
- Experience within Usability engineering
- An educational background in healthcare, health sciences, engineering, or similar – what truly interests us is your drive and out-of-box thinking
- A technical interest with a patient-centric mindset
- Experience in data collection and test methodology
- Experience working with defining product risks and product requirements on different levels
- An honest communication style, a collaborative mindset, and enthusiasm for the field
- Strong communication skills, with professional fluency in English, both written and spoken
On a personal note, you are proactive and have a pragmatic approach to your tasks. Based on the role, a strategic mindset and excellent stakeholder management skills are the key to success.
The Team
You will join a global team of 11 experts in Design Validation and Usability – with one common goal: Improving patient care and saving lives.
Collaboration and knowledge sharing are central to our team, giving you ample opportunities to contribute your expertise and engage in discussions about usability and design validation options.
When to apply
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. For further inquiries please contact Design validation and Usability Manager, Emilie O’Gara, at emog@ambu.com or at +45 5074 8574. Your application will be treated confidentially.
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.