Senior Device Technical Operations Engineer

Merck & Co.; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Long-term incentive

Job summary

Merck & Co. is seeking a Senior Engineer to lead Device Technical Operations within the Device Development and Technology Organization. You will help build capabilities for medical devices and combination products, manage internal/external manufacturing, and drive design transfer for complex drug-delivery systems.

This role emphasizes safety, quality, and regulatory compliance. You will work on autoinjectors, ophthalmic and inhalation products, and partner with global teams to ensure robust

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or related field.
• 5+ years in pharma, biologics, medical devices, or combination products.
• Experience with design controls and regulatory compliance.

Responsibilities

• Apply design controls, design transfer, and verification testing for devices.
• Support internal and external component and device manufacturing globally.
• Identify root causes and implement robust corrective actions.
• Lead development and lifecycle management for medical devices and combos.
• Ensure compliance with GMP, ISO 13485, and regulatory standards.
• Collaborate with partners to plan technology transfer and scale-up.

Skills

Design Controls

Risk Analysis

Process Validation

Injection Molding

Automation

Regulatory Compliance

Engineering Leadership

GMP Documentation

Materials Science

Mechanical Engineering

Education

Bachelor's in Engineering

Master's or PhD preferred

Job description

Merck & Co. is seeking a Senior Engineer to lead Device Technical Operations within the Device Development and Technology Organization. You will help build capabilities for medical devices and combination products, manage internal/external manufacturing, and drive design transfer for complex drug-delivery systems.

This role emphasizes safety, quality, and regulatory compliance. You will work on autoinjectors, ophthalmic and inhalation products, and partner with global teams to ensure robust