Senior Scientist, Drug–Device Design Verification

MSD Malaysia; Rahway, Northern (NJ, KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist to lead design verification and testing strategies for drug-device combination products. You will drive plan development, protocol design, and validation activities across departments to ensure clinical readiness and regulatory success.

The role requires strong project leadership, deep knowledge of device and drug development, and collaboration with external partners for testing and regulatory commitments.

Qualifications

• B.S./M.S./Ph.D. in Mechanical Engineering or equivalent.
• 8+ years of combination product development experience (flexible by degree).
• Leadership in design verification programs with cross-disciplinary teams.

Responsibilities

• Lead design verification plan, protocol, and reports demonstrating design output meets inputs.
• Oversee test method development/validation and testing readiness.
• Coordinate with external partners for verification activities and regulatory submissions.
• Drive risk management and DFMEA alignment across product programs.

Skills

Combination Products

Control Strategy

Design Controls

DFMEA

Design Verification Testing

Device Development

Drug Development

Project Leadership

Quality Management Systems (QMS)

Test Method Validation

Test Procedure Development

Education

B.S. in Mechanical Engineering

M.S. in Mechanical Engineering

Ph.D. in Mechanical Engineering

Tools

SolidWorks

Instron

Zwick

XRCT

Keyence

TA Instrument

Job description

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist to lead design verification and testing strategies for drug-device combination products. You will drive plan development, protocol design, and validation activities across departments to ensure clinical readiness and regulatory success.

The role requires strong project leadership, deep knowledge of device and drug development, and collaboration with external partners for testing and regulatory commitments.