Principal Engineer, Drug-Device Assembly & Process Development

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

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a hands-on medical device product manufacturing and assembly engineer for the DD&T group.

You will lead plans for assembly processes and equipment development, and collaborate with multiple suppliers and internal sites to support clinical and commercial programs. The role emphasizes leading technical teams, creating FMEAs, and executing validation protocols while ensuring quality attributes and risk controls are in place.

Qualifications

• B.S. degree and 15+ years of regulated industry experience.
• Experience designing automated assembly equipment for medical devices.
• Ability to develop and lead plans for product assembly processes and equipment development.

Responsibilities

• Develop detailed plans for product assembly process and equipment development; lead technical teams to deliver qualified processes and equipment for clinical or commercial use.
• Author design/Process FMEA to capture risks and implement controls.
• Design and author Process validation activity and documentation (IQ, OQ, PPQ).
• Manage equipment suppliers and oversee site readiness and documentation.

Skills

Assembly Processes

DFMEA

DFM

DFA

CAPA Management

Design for Manufacturing

Design Verification Testing

Medical Device Manufacturing

Equipment Designing

Troubleshooting

Education

B.S. in Mechanical Engineering or related field with 15 years regulated industry experience

Tools

SOLIDWORKS

3D Printing

Vision systems

Ultrasonic welding

Job description

Merck & Co., Inc. in Rahway, NJ, seeks a hands-on medical device product manufacturing and assembly engineer for the DD&T group.

You will lead plans for assembly processes and equipment development, and collaborate with multiple suppliers and internal sites to support clinical and commercial programs. The role emphasizes leading technical teams, creating FMEAs, and executing validation protocols while ensuring quality attributes and risk controls are in place.