Description
The Senior Systems/V&V Engineer will be one of the more senior members of this team. Responsibilities include: leading V&V activities related to new product development and on-market products; reviewing, assessing, and supporting mitigation of verification and validation technical risks; tracking closure of systems verification/validation issues and ensuring documentation; supporting and providing input to development of user needs and product requirements; providing content for the Design Input Reviews as required by the project teams; executing test plans and providing data for reports in a medical devices industry, including tracking of system issues based on risk analysis for appropriate disposition and; reviewing user needs, design inputs and design specifications for verification and validation applicability.Desired Skills & Experience- Bachelor's or Master's degree
- At least 5-9 years experience in Verification and Validation of Medical Devices
- Ability to develop test plans, protocols and to execute V&V tests to ensure that product designs meet design requirements and intended use
- Advanced experience utilizing engineering product development methodologies including validation of user needs by interacting with end users to gather data
- Aptitude for applying medical knowledge and human factors considerations to set up or assess workflows, interfaces, or interactions of users for test derivation
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