Validation SME - Design Validation
KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotive, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.
Job Title: Validation SME
Remote Role
Description
We are seeking a Validation Subject Matter Expert (SME) to lead design validation activities, including gap assessments and remediation efforts. This role ensures that medical devices meet user needs and intended use through effective integration of verification and validation (V&V) activities along with clinical and preāclinical data. The ideal candidate will support validation strategy development and ensure compliance with regulatory and quality standards.
Responsibilities
ā¢ Assess gaps in validation plans, protocols, and supporting evidence linking Design Inputs to user needs and clinical performance.
ā¢ Develop or update validation strategies, including simulatedāuse and human factors testing.
ā¢ Review validation results and ensure traceability to risk management and design outputs.
ā¢ Collaborate with Clinical and PreāClinical SMEs to ensure integrated validation evidence.
ā¢ Support regulatory justifications and Design Transfer documentation for validated processes.
Apply tot his job
Apply To this Job
Job Title: Validation SME
Remote Role
Description
We are seeking a Validation Subject Matter Expert (SME) to lead design validation activities, including gap assessments and remediation efforts. This role ensures that medical devices meet user needs and intended use through effective integration of verification and validation (V&V) activities along with clinical and preāclinical data. The ideal candidate will support validation strategy development and ensure compliance with regulatory and quality standards.
Responsibilities
ā¢ Assess gaps in validation plans, protocols, and supporting evidence linking Design Inputs to user needs and clinical performance.
ā¢ Develop or update validation strategies, including simulatedāuse and human factors testing.
ā¢ Review validation results and ensure traceability to risk management and design outputs.
ā¢ Collaborate with Clinical and PreāClinical SMEs to ensure integrated validation evidence.
ā¢ Support regulatory justifications and Design Transfer documentation for validated processes.
Apply tot his job
Apply To this Job