Validation SME (Remote)

Validation Subject Matter Expert (SME)Role SummaryThe Validation Subject Matter Expert (SME) will lead and support design validation activities to ensure medical devices meet user needs and intended use. This role is responsible for assessing validation gaps, remediating deficiencies, and integrating verification & validation (V&V), clinical, and pre-clinical evidence to support compliant design outcomes and regulatory submissions.Key ResponsibilitiesEvaluate and remediate gaps in design validation plans, protocols, and evidence to ensure alignment between Design Inputs, user needs, and clinical performance.Develop, revise, and execute validation strategies, including simulated-use, usability, and human factors studies.Review and interpret validation data, ensuring traceability to risk management files, design outputs, and clinical requirements.Partner with Clinical and Pre-Clinical subject matter experts to integrate validation evidence across disciplines.Support regulatory submissions, design transfer activities, and documentation for validated processes and design changes.QualificationsBachelor’s degree or higher in Engineering, Life Sciences, Human Factors, or a related discipline.Proven experience in medical device design validation under ISO 13485 and 21 CFR 820.Strong expertise in usability engineering and human factors validation (IEC 62366), statistical validation methods, and clinical correlation.Demonstrated success leading validation gap assessments and remediation efforts for Design History File (DHF) projects.Solid understanding of risk-based validation approaches and human factors requirements.