Join us in shaping the future of digital cardiology. We're looking for a Software Design Quality Engineer to lead project management, testing, validation and verification (in line with IEC for our CE-marked software EchoRapp, which aims to make echocardiography faster, smarter, and more accessible. If you have experience bridging clinical practice and software development, and want to help shape the next generation of echocardiography reporting, we'd love to hear from you.
More info here and application page here:
Software design quality engineer (80%-100%)
* 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.
* 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 and QMS requirements.
* Support CAPA processes, SOP updates, and 3rd-party audits.
Arbeitsort
Zurich Kartenansicht
Homeoffice (gemäss internen Richtlinien)
MediRapp AG
Frau Paola Daniore
Klosbachstrasse 104
8032 Zurich