Validation Engineer - Medical Devices

Title: Validation Engineer - Medical DevicesLocation: NVJob Summary:We are seeking an experienced Validation Engineer with 5–7 years of hands-on experience in the medical device industry. The ideal candidate will be responsible for executing and supporting validation activities to ensure compliance with regulatory standards and internal quality systems.Responsibilities:Execute process, equipment, and product validations (IQ/OQ/PQ)Develop, review, and approve validation protocols and reportsSupport process validation for new product introductions (NPI)Perform risk assessments (FMEA) and implement mitigation strategiesEnsure compliance with FDA, ISO 13485, and GMP requirementsCollaborate with cross-functional teams (Quality, Manufacturing, R&D)Conduct revalidation activities and change control assessmentsAnalyze validation data and provide recommendations for improvementsSupport audit readiness and regulatory inspectionsRequirements:Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field)5–7 years of validation experience in medical devices or regulated industryStrong knowledge of IQ/OQ/PQ, CSV, and process validationFamiliarity with GxP, FDA regulations, ISO 13485Experience with statistical tools (Minitab preferred)Good understanding of risk management and documentation practicesStrong communication and documentation skillsPreferred:Experience in sterilization validation / packaging validationExposure to cleanroom environmentsSix Sigma or Lean certification is a plus