Validation Engineer

Responsibilities:Execute comprehensive verification of digital infrastructure and automated platforms.Generate technical specifications and operational flowcharts alongside hazard evaluations.Draft formal validation strategies as well as testing scripts and final summary data.Uphold strict adherence to FDA regulatory standards for all manufacturing hardware and digital tools.Partner with internal departments to define and record necessary functional parameters.Lead various high-stakes initiatives simultaneously under tight deadlines.Navigate shifting business needs while maintaining high output with little oversight.Requirements:A minimum of five years dedicated to verifying digital systems within the medical technology sector.Proven background in software quality oversight and lifecycle testing.Medical Software and Lifecycle testing experience.Extensive familiarity with 21 CFR 820 compliance and medical manufacturing quality frameworks.Exceptional aptitude for resolving complex technical hurdles and making data-driven choices.Effective communication style for both independent work and group dynamics.Undergraduate or advanced degree in a physical science or engineering discipline.Practical experience managing Corrective and Preventive Actions (CAPA) and risk mitigation.Functional knowledge of metrology and the use of specialized gauging equipment.Proficiency in professional scheduling tools such as Smartsheet or Microsoft Project.Refined social skills and the ability to build rapport with diverse technical teams.