Senior Scientist, Drug-Device Combination Verification

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. Rahway, NJ is seeking an Associate Principal Scientist to lead end-to-end testing strategies for drug-device combination products.

You will drive design verification, method development/validation, and regulatory interfacing across development to commercialization, partnering with manufacturing, regulatory, and quality teams. The role emphasizes leadership, cross-functional collaboration, and the ability to influence at multiple levels while delivering robust verification and

Qualifications

• Bachelor's/Master's/PhD in Mechanical Engineering with 3–8+ years in combination product development.
• Leadership experience of design verification programs with cross-disciplinary teams.
• Strong knowledge of device development and design verification interdependencies with risk management and quality systems.

Responsibilities

• Lead and align stakeholders to execute design verification strategies.
• Define inputs/outputs and lead design verification plans, protocols, and reports.
• Develop test methodologies and validation activities for device components and final assemblies.
• Oversee third-party testing and provide oversight for testing readiness and execution.
• Support regulatory submissions (INDs/NDAs/BLAs) and clinical supplies production.
• Maintain engagement with cross-functional teams and stay current with industry standards.

Skills

Design Verification

Project Leadership

Regulatory Knowledge

Cross-functional Collaboration

Technical Writing

Strategic Thinking

Communication Skills

Travel readiness

Education

B.S. in Mechanical Engineering

M.S. in Mechanical Engineering

Ph.D. in Mechanical Engineering

Tools

Solidworks

Instron

Zwick

XRCT

Keyence

Job description

Merck & Co., Inc. Rahway, NJ is seeking an Associate Principal Scientist to lead end-to-end testing strategies for drug-device combination products.

You will drive design verification, method development/validation, and regulatory interfacing across development to commercialization, partnering with manufacturing, regulatory, and quality teams. The role emphasizes leadership, cross-functional collaboration, and the ability to influence at multiple levels while delivering robust verification and