Senior Device Engineering & Operations (Hybrid)

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

Benefits offered by this job

Medical insurance

Dental & Vision

401(k) retirement plan

Paid time off

Job summary

Merck & Co., Rahway, NJ, seeks a Senior Engineer - Device Technical Operations to drive design controls, design transfer, and risk management for medical devices and combination products. This role supports autoinjectors, ophthalmic and inhalation products across development and lifecycle, ensuring quality and regulatory alignment.

Hybrid work arrangement with global manufacturing partners, focusing on robust product development, technology transfer, and lifecycle support to sustain launches and

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related field; advanced degree preferred.
• Minimum 5 years in pharma/biologic/medical device or combination product engineering with at least 2 years in commercial manufacturing.
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation.

Responsibilities

• Utilize design controls, design transfer, and risk management to develop medical device solutions.
• Support internal and external component and combination product manufacturing globally.
• Identify issues from minimal signals and drive root-cause solutions.
• Build design engineering mindset for devices during development and lifecycle management.

Skills

Design Controls

Deviation Management

Engineering Leadership

Root Cause Identification

Regulatory Compliance

Problem Solving

Process Development

Quality Management Systems

Education

Bachelor’s degree in mechanical/biomedical engineering or related field

Advanced degree preferred

Tools

Injection Molding

Automation

Complex Assembly & Packaging

Job description

Merck & Co., Rahway, NJ, seeks a Senior Engineer - Device Technical Operations to drive design controls, design transfer, and risk management for medical devices and combination products. This role supports autoinjectors, ophthalmic and inhalation products across development and lifecycle, ensuring quality and regulatory alignment.

Hybrid work arrangement with global manufacturing partners, focusing on robust product development, technology transfer, and lifecycle support to sustain launches and