Hybrid Associate Principal Engineer, Drug-Device Assembly

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

Benefits offered by this job

Medical, dental, vision

401(k) and retirement benefits

Paid holidays and vacation

Sick days and compassionate days

Job summary

Merck & Co. seeks a hands-on Medical Device Manufacturing Engineer to lead assembly equipment development for combination products. You will work across internal sites and suppliers to deliver qualified processes for clinical or commercial use, authoring FMEA and validation plans.

The role emphasizes on-site and hybrid collaboration, with a focus on device design controls, documentation, and manufacturing readiness, including equipment qualification and process transfer.

Qualifications

• B.S. degree in Mechanical Engineering or related field; regulated industry experience is required.
• Experience designing automated assembly equipment and managing equipment suppliers.
• Familiarity with DFMEA, DFA, DFM and design controls in medical device manufacturing.

Responsibilities

• Develop detailed plans for product assembly process and equipment development and lead technical teams to deliver qualified processes and equipment for clinical or commercial use.
• Author design/process FMEA and identify risk controls to ensure robust device functionality.
• Design and author process validation activities and documentation (IQ/OQ/PPQ).
• Create drawings and specifications ensuring proper development documentation per SOPs.
• Collaborate with internal sites and suppliers to transfer processes and technologies.

Skills

Assembly Language (ASM)

Assembly Processes

CAPA Management

Combination Products

DFMEA

DFA

DFM

Design Verification Testing

Device Design

Design Controls

DFMEA

DFMA

Documentation Preparation

Engineering Support

Equipment Designing

Equipment Engineering

Fixtures Design

Human Factor Engineering

Manufacturing Strategies

Mechanical Testing

Medical Device Manufacturing

Education

B.S. Degree in Mechanical Engineering or related field

Tools

SOLIDWORKS

3D Printing

Job description

Merck & Co. seeks a hands-on Medical Device Manufacturing Engineer to lead assembly equipment development for combination products. You will work across internal sites and suppliers to deliver qualified processes for clinical or commercial use, authoring FMEA and validation plans.

The role emphasizes on-site and hybrid collaboration, with a focus on device design controls, documentation, and manufacturing readiness, including equipment qualification and process transfer.