Software Design Quality Engineer

Software Design Quality Engineer (80%-100%)

Join to apply for the Software Design Quality Engineer (80%-100%) role at Medi Rapp AG

About Medi Rapp:
Join us in shaping the future of digital cardiology. You will play a pivotal role in Medi Rapp’s vision to make high‑quality echocardiography accessible in every cardiology practice and hospital worldwide. Through our CE‑Marked software Echo Rapp, you will help turn this vision into reality by making echocardiography faster, more accurate, and more accessible, empowering cardiologists to deliver better care to every patient.

Role overview:
We are looking for a proactive Software Design Quality Engineer to lead the testing, validation, and quality assurance of Echo Rapp’s cardiac AI imaging and reporting software. The SDQE will design and execute detailed test plans, verify new features, identify and resolve errors in AI and imaging workflows, and ensure all functionalities are fully traceable and compliant with CE and FDA regulatory processes.

Working closely with our developers and cardiologists, the SDQE will oversee risk‑based testing, support change controls and design documentation, and help deliver a clinically robust, audit‑ready product for clinical use.

• Lead testing, verification, and validation of Echo Rapp’s AI‑powered cardiac imaging and reporting software based on IEC 62304.
• Develop and own the software testing, validation and verification strategy.
• Translate clinical and regulatory requirements into detailed feature deliverables and design outputs.
• Plan and participate in Agile software development cycles, including SCRUMs and review of testing/verification/validation deliverables.
• Update documentation required for CE Class IIa and FDA 510(k) submissions.
• Ensure traceability, audit readiness, and compliance with ISO 13485, ISO 14971 and IEC 62304 requirements.
• Support CAPA processes, SOP updates, and 3rd‑party audits.

• Master’s degree in engineering or a scientific discipline; advanced degree preferred.
• Proven experience in software testing, validation, and quality assurance in the medical devices industry or a similar regulated environment.
• Experience with test automation frameworks (e.g., Playwright).
• Familiarity with industry standards and regulations such as ISO 13485, IEC 62304, FDA regulations, and other relevant guidelines.
• Familiarity with SaMD, Agile/Dev Ops processes, and design control.
• Familiarity with tools such as JIRA, Confluence, or JAMA.
• Ability to work in a fast‑paced, dynamic environment and adapt to changing priorities.
• Strong communication skills for cross‑functional collaboration.
• Fluency in both German and English preferred.

• Work from home: 2 days per week.
• Health Insurance: coverage of 60% of premiums for employee and dependents.

Submit your CV and cover letter here: https://(Use the "Apply for this Job" box below).-engineer

Seniority level:
Entry level |

Employment type:

Full‑time | Job function:
Engineering and Information Technology | Industry: Hospitals and Health Care