Associate Director, Drug​/Device Combination Products Tech Transfer

Overview

The Associate Director – Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position provides strategic program leadership, technical expertise, and project management in the scale‑up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The role collaborates with a team of engineers and technical staff to support global and site‑specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company s business goals, quality and regulatory compliance.

• Program Leadership and Technical Project Management:
  Provide program leadership in the development, commercialization, transfer, and sustained launch of medical devices and combination products globally.
• Develop and execute strategic plans for technology transfer, problem solving, and collaboration with receiving sites, drug product partners, Technical Product Leaders, regulatory, and quality teams.
• Provide Voice of Manufacturing input to early development teams to ensure manufacturing needs are considered in design; drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercialization.

• 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 development and lifecycle management, ensuring regulatory compliance.
• Ensure robust technical plans, risk communication, and drive technical and program decisions through the development team and governance forums.
• Author and complete regulatory filing sections, and support responses to questions and pre‑approval inspections from a product development perspective.

• Secure early sponsorship and stakeholder alignment for projects, effectively communicating decisions and expectations to key stakeholders and sponsors.
• Foster a culture of inclusion by integrating inputs from various sources to meet customer and stakeholder needs.
• Build strategic partnerships with manufacturing sites and partner groups.

• Ensure activities emphasize safety, quality, and regulatory compliance, aligning with divisional and local site procedures.
• Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems.

Education

• Required
  :
  Technical BS degree or higher

Preferred

• BS or MS in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

Experience

• 8+ years of experience in medical device or combination product engineering.
• Demonstrated technical leadership in Technology Transfer and Design Transfer for medical devices and combination product manufacturing, with experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with strong understanding of quality management systems and regulatory compliance.
• Exceptional project management and communication skills, including collaboration with combination product development teams and working groups.

• Current Employees apply HERE
• Current Contingent Workers apply HERE

US And Puerto Rico Residents Only

Our company is committed to inclusion. Please  if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with…