My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Verification SME based in Remote (EST) with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

Role: Verification SME
Location: Remote (EST)

Summary:
Mid-to-senior level (5 10+ yrs). Largest headcount role in the program. Provides specialized expertise in design verification - gap assessment and remediation of verification plans, protocols, and results across all subsystems.

Key Responsibilities

• Conduct gap analyses of verification strategies, protocols, and traceability matrices
• Develop or update verification test methods, acceptance criteria, and statistical sampling plans
• Oversee execution or review of verification activities and resolve discrepancies
• Integrate verification results into risk management and DHF documentation
• Support cross-functional alignment with validation and design transfer activities

Required Qualifications

• Degree in Engineering or related field
• Medical device design verification experience under ISO 13485 and 21 CFR 820
• Deep expertise in test method development, statistical analysis, and verification reporting
• Prior experience leading verification gap assessments or remediation programs
• Proficiency with requirements traceability and risk-based verification approaches