Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

Merck seeks an Associate Principal Scientist to lead design verification strategies for drug-device combination products across their development lifecycle. The role requires technical expertise in design controls, testing methodologies, and cross-functional collaboration to support clinical readiness and regulatory submissions.

Responsibilities

• Lead design verification strategies and execution for drug-device combination product programs
• Define design inputs/outputs and author design verification plans, protocols, and reports
• Develop and validate test methodologies internally and with external partners
• Direct accelerated and real-time aging studies at component and combination product levels
• Author and review regulatory submission documents (INDs, IMPDs, NDAs, BLAs, etc.)

Requirements

• B.S. in Mechanical Engineering or equivalent with 8+ years combination product development experience
• M.S. in Mechanical Engineering or equivalent with 5+ years combination product development experience
• Ph.D. in Mechanical Engineering or equivalent with 3+ years combination product development experience
• Leadership experience managing design verification programs and cross-disciplinary project teams
• Deep knowledge of design controls, risk management, materials, molding, process development, and design validation
• Comprehensive understanding of drug product manufacturing and combination product testing requirements