Senior Device Technical Operations Engineer

Merck & Co.; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Merck & Co. in Rahway, NJ, seeks a Senior Engineer - Device Technical Operations to advance medical device and combination product development, scale-up, and tech transfer.

This role focuses on design controls, risk management, and verification for autoinjectors, ophthalmic, and inhalation products, coordinating with internal and external manufacturing teams to ensure robust launches. You will lead lifecycle management, regulatory readiness, and cross-functional collaboration in a global

Qualifications

• Bachelor's degree in mechanical, biomedical, or related engineering; advanced degree preferred.
• Minimum 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 a strong understanding of quality management systems and regulatory compliance.
• Demonstrated technical experience in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing. Direct experience in autoinjectors, ophthalmic products, or inhalation products 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 responses regulatory agency questions and pre-approval inspections during product development and life cycle management
• Develop and execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal partners.
• Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
• Build strategic partnerships with manufacturing sites and partner groups
• Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.
• 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

Master's or PhD preferred

Job description

Merck & Co. in Rahway, NJ, seeks a Senior Engineer - Device Technical Operations to advance medical device and combination product development, scale-up, and tech transfer.

This role focuses on design controls, risk management, and verification for autoinjectors, ophthalmic, and inhalation products, coordinating with internal and external manufacturing teams to ensure robust launches. You will lead lifecycle management, regulatory readiness, and cross-functional collaboration in a global