You are responsible for
• Verification and Validation of the product(s) / product line(s)
• Testability review of the user needs, intended uses and system requirements
• Providing system V&V planning input, estimation and WBS to Test Manager
• Efficient V&V test strategy formulation for the System release
• The architecture of the test environment and test infrastructure
• Defining the entry, suspension, and exit criteria for System Verification
• Maintaining the System V&V Test Traceability Matrix (TTM)
• Defining Test automation scope and approach
• System Verification Specifications quality and completeness
• Assessing the Verification Baseline change impact and updating the System Verification Specification as appropriate
• Gathering Risk Assessment Test Verification Evidence
• Member of the Problem Report Management Team as of Release for Verification
• Complete design release V&V test evidence
To succeed in this role, you’ll need a customer-first attitude and the following.
• Bachelor/Master degree
• Extensive knowledge and experience on test discipline, test strategy, test authoring, reviews
• Several years of Medical Device Development / Testing. Preferably 8+ years
• Knowhow of design control processes for medical device design
• Experience in CT/AMI is preferred. Medical device testing knowledge is mandatory.
• Good application knowledge within project's scope
• Good understanding of development processes (software/hw/mechanical) in general
• Hazard and norm compliance knowledge
• Understanding of healthcare regulatory procedures and conformities
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