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Kasmo Global

Minneapolis / Global

Software Validation Engineer

Job Description

Software Validation EngineerWork Location: Plymouth, MN - Day 1 onsiteDuration: ContractBachelor's degree in Computer Science, Information Technology, Electronics Engineering, or a related fieldMinimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries.Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principlesExperience in handling SW development and verification toolsGood exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation.Experience with computerized system validation (CSV) approaches for non-product applicationsProficiency in authoring validation documents as per SOP or work instruction.Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test executionWork with cross functional team and SME to understand the intended use and prepare the above documentation
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