Software Validation Engineer Remote Location

Plymouth MNJob Description:>> Bachelors degree in Computer Science, Information Technology, Electronics Engineering, or a related field required>> Minimum 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 principles>> Experience in handling SW development and verification tools>> Good 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 applications>> Proficiency in authoring validation documents as per SOP or work instruction>> Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test execution>> Work with cross functional team and SME to understand the intended use and prepare the above documentationRequirements:>> Bachelors degree in Computer Science, Information Technology, Electronics Engineering, or a related field>> Minimum 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 principles>> Experience in handling SW development and verification tools>> Good 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 applications>> Proficiency in authoring validation documents as per SOP or work instruction