Required skills
- Software Verification
- Medical Device Software
- Verification and Validation
- Software Quality Assurance
- Test Design
- Test Management
- Design Verification Testing
- VTESTSTUDIO
- Python
- CAPL
- Polarion
- DOORS
Languages: German
Job description
Develop and implement verification strategies for software-controlled medical devices, design and execute test cases, and support regulatory submissions.
Responsibilities
- Develop and implement verification strategies for software-controlled medical devices at subsystem and system level.
- Design and execute test cases based on requirements and risk analysis.
- Set up and maintain test fixtures and test stands for manual and automated tests.
- Create and deploy test automation scripts and frameworks.
- Document verification according to FDA and MDR specifications and support regulatory submissions.
- Evaluate test results and record defects in the bug tracking system.
- Collaborate with software, hardware, system engineering, and clinical teams for seamless verification.
- Maintain, improve, and expand test environments.
Requirements
- 3 to 5 years of experience in software and system verification, ideally in the medical device sector.
- Experience with test design, test execution, and defect reporting, as well as analytical thinking.
- Good documentation skills for V&V documents according to FDA and MDR.
- Experience with requirements and test management tools, e.g., Polarion or DOORS.
- Basic knowledge of scripting and test automation, e.g., Python, CAPL, or VTestStudio.
- Advantageous: CAN bus and Vector tools (CANoe), knowledge of IEC 60601-1 and IEC 62304, experience with test stand or fixture design.
- Good English (spoken and written), German is a plus.
Project details
ASAP
9 months
40 hours/week
Location Bavaria
- Start: ab sofort
- Duration: 9 Monate
- Remote: onsite
- Location: Bayern, Deutschland, DE
- Languages: German
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