Senior Device Ops Engineer: Tech Transfer & Manufacturing

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

Job summary

Merck seeks a Senior Engineer - Device Technical Operations to build capabilities for medical devices and combination products. The role manages internal and external manufacturing for development, scale-up, and design transfer of devices with autoinjectors, ophthalmic and inhalation products.

The position requires deep expertise in design controls, risk management, and process validation, supporting regulatory inspections and technology transfer while driving product robustness for sustained

Qualifications

• Bachelor’s degree in engineering; advanced degree preferred.
• Minimum of 5 years in pharmaceutical, biologic, medical device or combination product engineering with at least 2 years supporting commercial manufacturing.
• Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation with strong quality/regulatory knowledge.
• Experience in injection molding, automation, complex assembly and packaging for medical devices; autoinjectors, ophthalmic or inhalation products preferred.

Responsibilities

• Utilize design controls, design transfer, control strategies, device risk management, and verification testing to develop value-added solutions.
• Support internal and external component and combination product manufacturing globally.
• Identify issues from minimal signals; perform root cause analysis and implement solutions.
• Build design engineering mindset for medical devices in development and lifecycle management; ensure regulatory compliance.
• Use best practices to optimize design and manufacturing decisions across teams during development and commercialization.
• Support regulatory agency questions and pre-approval inspections during product development and life cycle.
• Develop and execute strategic plans for technology transfer and late-stage development; collaborate with internal and external partners.
• Foster inclusion by integrating inputs from diverse sources to meet customer needs.
• Build strategic partnerships with manufacturing sites and partner groups.
• Ensure safety, quality, regulatory compliance; align with site procedures.
• Support regulatory inspections and maintain ISO 13485, ISO 14971-2019, and other QMS.

Skills

Design Controls

Risk Analysis

Control Strategies

Deviation Management

Engineering Leadership

Engineering Support

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

Job description

Merck seeks a Senior Engineer - Device Technical Operations to build capabilities for medical devices and combination products. The role manages internal and external manufacturing for development, scale-up, and design transfer of devices with autoinjectors, ophthalmic and inhalation products.

The position requires deep expertise in design controls, risk management, and process validation, supporting regulatory inspections and technology transfer while driving product robustness for sustained