Associate Director

Job Overview The Associate Director – Device Tech Transfer is a leadership role within the Device Development and Technology Organization. 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, focusing on autoinjectors, prefilled syringes, and other drug delivery systems. Responsibilities 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, and Technical Product Leaders, regulatory and quality. Provide Voice of Manufacturing input to early development teams to ensure manufacturing needs are considered as part of the design. Conduct early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products. Utilize extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value‑added solutions. Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards. 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 response to questions and pre‑approval inspections from a product development standpoint. Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors. Build strategic partnerships with manufacturing sites and partner groups. Ensure 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 ISO13485, ISO14971, and other relevant quality management systems. Qualifications Education – Technical BS degree or higher. Preferred: BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar. 10+ years of experience in medical device or combination product engineering. Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific 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 a strong understanding of quality management systems and regulatory compliance. Exceptional project management skills and principled verbal and written communication abilities, and experience collaborating with combination product development teams and working groups. Required Skills Commercialization Design Controls Design Engineering Design Verification Manufacturing Compliance Manufacturing Methodologies Materials Engineering Medical Devices Medical Devices Design Medical Product Development Product Design Product Development Design Project Management Prototyping Regulatory Compliance Regulatory Inspections Stakeholder Management Technical Leadership Technology Transfer EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Benefits Salary range: $142,400.00 – $224,100.00 Annual bonus and long‑term incentive, if applicable. Medical, dental, vision, and other insurance benefits for employee and family. Retirement benefits, including 401(k). Paid holidays, vacation, compassionate, and sick days. Application Information Apply through jobs.merck.com/us/en or the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting. Application helps us consider qualified applicants in compliance with the San Francisco Fair Chance Ordinance and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Job Posting End Date 07/28/2026 #J-18808-Ljbffr