ACCREA Medical Robotics is a pioneering company that creates intelligent robotic systems for medicine and surgery. We combine advanced mechanics, electronics, and software to deliver solutions that support doctors in precise procedures and improve patient safety.
Due to the dynamic development of new devices and the need to meet rigorous quality standards (including medical standards), we are looking for a Software Tester. This person will play a key role in ensuring the highest reliability and safety of our systems by building and executing comprehensive test procedures.
Role Purpose
The Software Tester will be responsible for ensuring the highest quality and safety of medical software through comprehensive planning, execution, and documentation of testing processes. The key objective is to verify system compliance with design requirements and rigorous regulatory standards (including IEC 62304, ISO 13485), which directly contributes to successful product certification (CE/FDA) and the market introduction of reliable medical robotics solutions.
Responsibilities
- Creating test plans, scenarios, and test cases in accordance with design and regulatory requirements (IEC 62304, ISO 13485, ISTQB).
- Performing manual tests and documenting their progress and results.
- Participation in integration, validation, system, and UAT tests.
- Documenting and reporting bugs in accordance with traceability requirements.
- Proposing changes to increase consistency, usability, and quality of the entire system.
- Working with requirements and defect management tools (e.g., Jira, Jama, TestLink).
- Collaboration with engineering, clinical, and regulatory affairs teams.
- Participation in preparation of CE / FDA certification documentation.
- Ensuring compliance with ISO and FDA standards (Design Verification & Validation).
- Analysis of test results, evaluation of test scenarios.
- Supporting the development and design teams.
Key Requirements
- Minimum 2 years of experience as a software tester (preferably in medical or regulated environments).
- Knowledge of standards and norms: ISO 13485, MDR, ISTQB.
- Ability to work in accordance with traceability and GxP requirements.
- Experience in creating test documentation for audits and certification purposes.
- Knowledge of medical device life cycle and SDLC (e.g., Waterfall, Agile).
Preferred Qualifications
- Experience in testing embedded devices and/or clinical applications.
- Knowledge of programming environments (e.g., Python, C++) – for log or script analysis.
- English language skills sufficient for working with technical documentation.
Ready for the Challenge?
Join the ACCREA team and help us revolutionize robotic surgery.