Lead Drug-Device Assembly & Manufacturing Engineer

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

Benefits offered by this job

Medical, dental, vision insurance and

401(k) retirement benefits

Paid holidays and vacation

Job summary

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

You will work on development and assembly of devices, collaborating with internal sites and suppliers to support combination product processes and quality requirements. The role emphasizes hands-on floor work, cross-functional teamwork, and adherence to regulatory standards, with responsibilities spanning process validation, equipment qualification, and

Qualifications

• B.S. Degree in Mechanical Engineering with 15 years of regulated industry experience.
• Experience designing automated assembly equipment and managing equipment suppliers.
• Familiarity with DFMEA, DFA, DFM and design controls.

Responsibilities

• Develop detailed plans and strategies for assembly process and equipment development and lead technical teams to deliver a qualified process for clinical or commercial use.
• Author DFMEA to capture design risks and implement controls for robust device functionality.
• Design and author process validation activities and documentation (IQ, OQ, PQ).
• Prepare protocols, reports, drawings and specifications ensuring documentation per SOPs.
• Experience in designing automated assembly equipment and managing suppliers.

Skills

DFMEA

DFA

DFM

Design Controls

Quality Systems

Education

B.S. Degree in Mechanical Engineering

Tools

SOLIDWORKS

3D Printing

Job description

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

You will work on development and assembly of devices, collaborating with internal sites and suppliers to support combination product processes and quality requirements. The role emphasizes hands-on floor work, cross-functional teamwork, and adherence to regulatory standards, with responsibilities spanning process validation, equipment qualification, and