Senior Design Validation Engineer – Medical Device Software (m/f/d)

Responsibilities

• Defining and taking responsibility for the end-to-end validation strategy for the planning software
• Independently creating and managing V&V plans, protocols, traceability matrices, and reports
• Preparing validation-related documentation for regulatory submissions (SaMD)
• Validation of algorithm performance and definition of requirements for validation data sets for AI/ML components
• Assessment of existing software and documentation, as well as identification of V&V gaps
• Pragmatic remediation of documentation and improvement of quality processes
• Coordination of internal teams during the validation process

Requirements