Hybrid Senior Engineer, Device Tech Operations

MSD Malaysia; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck seeks a Senior Engineer - Device Technical Operations to drive design controls, risk management, and technology transfer for medical devices and combination products in a global development and manufacturing setting.

Responsibilities include supporting internal and external manufacturing, optimizing design verification, and ensuring regulatory compliance across development and lifecycle stages.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering with advanced degree preferred.
• Minimum of 5 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years supporting commercial manufacturing.
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with strong regulatory knowledge.

Responsibilities

• Utilize extensive experience in design controls, design transfer, control strategies, device risk management, and design verification testing to develop value-added solutions.
• Provide support for internal and external component manufacturing and combination product manufacturing, globally.
• Identify issues with minimal signals, problem solving, root cause analysis, and delivering solutions.
• Build design engineering mindset for medical devices in development and lifecycle management, ensuring regulatory compliance.
• Support regulatory responses and pre-approval inspections during product development and life cycle management.
• Develop and execute strategic plans for technology transfer and late-stage development with external and internal partners.

Skills

Construction Processes

Design Controls

Deviation Management

Driving Continuous Improvement

Engineering Leadership

Engineering Support

Ethical Compliance

GMP Documentation

Materials Science

Mechanical Engineering

Performance Monitoring

Process Development Engineering

Product Engineering

Root Cause Identification

Technology Development

Education

Bachelor's degree in mechanical engineering, biomedical engineering, or related technical field

Advanced degree (Master's or PhD) preferred

Job description

Merck seeks a Senior Engineer - Device Technical Operations to drive design controls, risk management, and technology transfer for medical devices and combination products in a global development and manufacturing setting.

Responsibilities include supporting internal and external manufacturing, optimizing design verification, and ensuring regulatory compliance across development and lifecycle stages.