Software Design Quality Engineer (80%-100%)

Join us in shaping the future of digital cardiology. You will play a pivotal role in MediRapp’s vision to make high-quality echocardiography accessible in every cardiology practice and hospital worldwide. Through our CE‑Marked software EchoRapp, 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.

We are looking for a proactive Software Design Quality Engineer to lead the testing, validation, and quality assurance of EchoRapp’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 functionality is 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.

Responsibilities

• Lead testing, verification, and validation of EchoRapp’s AI‑powered cardiac imaging and reporting software. Develop and own the software testing and validation strategy.
• Translate clinical and regulatory requirements into detailed software deliverables and design outputs.
• Support the software development lifecycle for SaMD, including design, implementation, and technical documentation.
• Conduct risk management in line with ISO 14971, including Risk Management Plans, Hazard Analyses, and Software FMEA.
• Review documentation required for CE Class IIa and FDA 510(k) submissions.
• Plan and participate in Agile development cycles, including SCRUMs and review of verification/validation deliverables.
• Ensure traceability, audit readiness, and compliance with ISO 13485, IEC 62304, ISO/IEC 42001, and QMS requirements.
• Support CAPA processes, SOP updates, and third‑party audits.

Requirements

• 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 such as Playwright.
• Familiarity with industry standards and regulations such as ISO 13485, IEC 62304, FDA regulations, and other relevant guidelines.
• Familiarity with SaMD, Agile/DevOps processes, and design control.
• Experience with AI‑driven medical software, cardiac imaging, SFMEA, and cybersecurity.
• 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.

What We Offer

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

Location: Zurich, Switzerland.