Director of Device Technology Transfer

2 weeks ago


Rahway, New Jersey, United States Merck Full time
Job Summary

The Director of Device Technology Transfer is a key leadership role within the Device Development and Technology Organization at Merck. This position is responsible for providing strategic program leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products.

Key Responsibilities
  • Provide program leadership in the development, commercialization, and transfer of medical devices and combination products globally.
  • Develop and execute strategic plans for technology transfer, problem-solving, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
  • Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design.
  • Utilize extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.
  • Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineer, or a related technical field required; advanced degree (Master's or PhD) preferred.
  • Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a leadership or management role.
  • Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging.
  • 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.


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