Senior Engineer - Drug-Device Combination Product Assembly

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) retirement

Paid holidays

Vacation days

Sick days

Job summary

MSD’s Device Development & Technology (DD&T) team in Research seeks a hands-on medical device manufacturing and assembly engineer. You will perform factory floor work and collaborate with internal sites, suppliers, and sub-suppliers to develop and qualify assembly processes and equipment for clinical or commercial use.

This role requires leading technical teams, conducting DFMEA and process validation (IQ/OQ/PPQ), writing protocols and specs, and managing equipment suppliers.

Qualifications

• B.S. Degree in Mechanical Engineering or related field with a minimum 15 years of regulated industry experience.

Responsibilities

• Develop detailed plans and strategies for combining product assembly process and equipment development and lead technical team to deliver a qualified process and equipment for clinical or commercial use.
• Author design/process FMEA to capture design risks and identify risk controls to ensure robust device functionality.
• Design and author Process validation activity and documentation like IQ, OQ, PPQ.
• Author protocols, reports, drawings and specifications to document development activities per SOPs.
• Experience in designing automated combination product assembly equipment and managing equipment suppliers.
• Experience with assembly equipment processes including vision systems, ultrasonic welding, and automated feeding/handling systems.
• Manage manufacturing site readiness including equipment qualification requirements and related documentation.
• Understand DFM/ DFA principles and their impact on assembly processes.
• Excellent communication to present complex information to stakeholders.
• Strong hands-on troubleshooting abilities and teamwork.

Skills

DFMEA

Process validation

IQ/OQ/PPQ

Design for Assembly

DFM

Equipment design

CAPA management

Manufacturing readiness

Vision systems

Ultrasonic welding

Education

B.S. Mechanical Engineering

Tools

SOLIDWORKS

3D printing

Job description

MSD’s Device Development & Technology (DD&T) team in Research seeks a hands-on medical device manufacturing and assembly engineer. You will perform factory floor work and collaborate with internal sites, suppliers, and sub-suppliers to develop and qualify assembly processes and equipment for clinical or commercial use.

This role requires leading technical teams, conducting DFMEA and process validation (IQ/OQ/PPQ), writing protocols and specs, and managing equipment suppliers.