Test Method Validation (TMV) SME

Job Overview

We are seeking experienced Test Method Validation (TMV) Subject Matter Experts to lead and support TMV execution activities for complex medical device validation projects. This is a senior-level role requiring extensive experience in test method validation, technical leadership, and mentoring validation teams. Candidates should have a strong background in software and hardware validation within regulated environments.

Key Responsibilities

• Lead and oversee TMV test execution activities for medical device validation projects.
• Provide technical guidance and mentorship to validation engineers during protocol execution.
• Review and support the development of TMV protocols, test methods, and acceptance criteria.
• Ensure validation activities comply with design controls, quality standards, and regulatory requirements.
• Monitor software and hardware validation testing, resolve execution issues, and ensure accurate documentation.
• Collaborate with cross-functional engineering and quality teams to support successful project execution.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 10+ years of U.S. experience as a TMV Lead, SME, Coach, or Validation Supervisor.
• Hands-on experience executing Test Method Validation (TMV) test cases.
• Strong background in software and hardware validation within the medical device industry.
• Excellent leadership, mentoring, and technical problem-solving skills.