Join Our Team
"Empower people to improve mental health" - join us on our mission to improve mental health care. At Elona Health, we develop tools that empower patients to take a more active role in their therapy and support psychotherapists in making better treatment decisions. Our digital health applications elona therapy Depression and elona explore have been recognized by BfArM as 'App on Prescription' and this is where your role is needed!
Your Responsibilities
As a
Regulatory & Quality Assurance Engineer, you play a key role in quality assurance and testing of our digital health applications. You conduct tests, identify potential risks, and ensure precise documentation according to ISO 13485 to guarantee compliance of our medical devices. This includes:
- Defining test requirements & analyzing specifications: You derive test requirements from product specifications and ensure our digital health applications (DiGA) meet regulatory and safety requirements.
- Conducting & documenting tests: You perform specification-based tests (unit and system tests) as well as manual tests, document test results in a structured manner, and derive optimization potentials.
- Error management & quality assurance: You identify, document, and prioritize found errors and work closely with product and development teams to resolve them.
- Usability engineering & risk management: You evaluate test results regarding usability aspects and assist in identifying and minimizing risks according to ISO 14971.
- ISO 13485-compliant test and documentation processes: You ensure that all testing activities comply with the requirements of ISO 13485, including documentation in the medical device lifecycle.
- Automation & further development of test strategy: You contribute to optimizing our test processes and support the conception and implementation of automated tests.
- Close collaboration with product development & QM: You work interdisciplinary with the product and quality teams to ensure regulatory requirements and highest quality standards.
Your Profile
- You have completed vocational training or studies, e.g., in medical technology, computer science, business informatics, or a comparable field.
- You are familiar with software lifecycle processes, writing test cases, and structured documentation.
- You approach others openly, can communicate complex issues clearly, and enjoy working in a team.
- You recognize patterns, analyze problems systematically, and have an eye for detail.
- Mental health is an important social issue for you, and you want to actively contribute to the development of the healthcare system.
- You communicate confidently in German (must-have) and English.
- Certifications & tools (advantageous, but not mandatory):
- ISTQB® Certified Tester Foundation Level
- Experience with Jira and Confluence
- Knowledge of Browserstack, Git, and test management tools is a plus
Why Us?
- Full flexibility: You can work from anywhere and at any time but also regularly contribute at our HQ in Düsseldorf
- We offer the latest technology and hardware
- The opportunity to develop yourself and take responsibility for topics you are passionate about
- You can help shape the future of mental health care and create a patient experience that helps people on the path to lasting recovery
- Work with purpose - your work can make a difference in the lives of many people with mental illnesses
- We are a cool team with motivation and expertise to advance the future of mental health care
- We grow with the challenges ahead - so do you. We offer space for personal development and a steep learning curve
About Us
The number of people receiving treatment for mental or behavioral disorders is growing every day. But while the world around us has changed enormously over the years, psychotherapy has hardly changed. We believe it is time for an update to improve mental health care for patients and therapists by building on their strengths - human interaction and person-centered therapy. That is why at Elona Health, we develop tools that empower patients and therapists alike to improve mental health.