Senior Device Operations Engineer — MedTech & Transfer

MSD; Pennsylvania; Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Retirement benefits (401(k))

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ / West Point PA area seeks a Senior Engineer to lead Device Technical Operations in a hybrid role. You will manage design transfer, risk control, and verification for medical devices and combination products, advancing autoinjectors, ophthalmic, and inhalation systems.

Collaboration with internal and external sites is required. The role requires a mechanical/biomedical background, 5+ years in pharma/medical devices, and experience with ISO 13485 and ISO 14971.

Qualifications

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field; 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; strong regulatory compliance knowledge.
• Direct experience in autoinjectors, ophthalmic products, or inhalation products is highly preferred.

Responsibilities

• Utilize extensive experience in design controls, design transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.
• Provide support for internal and external component manufacturing and combination product manufacturing, globally.
• Identify issues with minimal signals, problem solving, identification of root cause provides solutions.
• Build design engineering mindset for medical devices or combination products in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
• Use engineering best practices and tools to optimize the design and manufacturing to ensure robust technical and programs decisions through the development and commercialization teams.
• Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.

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

Tools

Injection molding

Automation

Complex assembly and packaging operations

Job description

Merck & Co., Inc. in Rahway, NJ / West Point PA area seeks a Senior Engineer to lead Device Technical Operations in a hybrid role. You will manage design transfer, risk control, and verification for medical devices and combination products, advancing autoinjectors, ophthalmic, and inhalation systems.

Collaboration with internal and external sites is required. The role requires a mechanical/biomedical background, 5+ years in pharma/medical devices, and experience with ISO 13485 and ISO 14971.