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Senior Usability and Design Validation Specialist

Location

Ballerup, Denmark, Augsburg, Germany

JobType

Full-time

About the job

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About the role

We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser's local storage. This includes cookies necessary for the website's operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the website's performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. 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 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.

About the company

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.

Skills

usability engineering
data collection
test methodology
product risks
product requirements