Software Validation Engineer

Position- Software Validation Engineer Location: Plymouth, MN-Day 1 onsite Note-Candidate should have knowledge in software testing, GAMP V, 21CFR part 11,QMS, ISO 13485 Bachelor's 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. 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 documentation

Created: 2026-03-04