System Integration
vor 3 Wochen
Our client is an innovative and fast growing medical devices company located in Lausanne.
**Responsibilities**:
- Manage and grow I&V team resources (Software System Testing, System Integration Testing and System Verification Testing) ;
- Establish the verification strategy at Software System, System Integration and System Verification testing and author the high-level verification plans for each stage of the development cycle ;
- Participate to design reviews and change control boards to ensure testability of the medical device ;
- Execute and coordinate the test cases writing, execution and reporting (including test results, coverage and traceability) ;
- Define the long-term strategy to support configuration management ;
- Collaborate with field service defining new tools and processed ;
- Author or contribute to requirement documentation, verification and validation plan and reports, and contribute to risk analysis in compliance with Class IIb medical device (i.e. IEC 62304, IEC 60601, ISO 14791) under a ISO 13485 Quality Management System.
**Profile**:
- At least 6 years of Software System and/or System Integration/Verification Testing in the context of embedded systems and/or mechatronics ;
- Experience with V-Model (or similar) development lifecycle ;
- Experience with requirements management tools (Polarion ALM, Doors or similar) ;
- Able to understand electronics (HW) schematics and translate them into test bench specifications for V&V ;
- Experience with ISO 13485, IEC 62304, IEC 60601, ISO 14971 standards ;
- Experience within MDD/MDR/FDA Submissions.
Permanent Contract
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