Overview
Associate Director, Device Technology – Merck
The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This position is responsible for building strategic leadership, technical expertise, and managing external partners 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 associate director will be a technical subject matter expert on the device components and combination products and lead a cross functional team members to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.
Responsibilities
- 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.
- Provide support for the external partner component manufacturing, release and distribution to global manufacturing sites.
- Identify issues with minimal signals, problem solving, identification of root cause, and provide 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.
- Support responses to 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.
- Provide Voice of Manufacturing input to early development teams to ensure manufacturing needs are considered as part of the design; drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
- 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.
- Lead, mentor, and enable the team to function as independent contributors, supporting global and site-specific projects related to combination products and drug delivery systems.
- Ensure all activities are conducted with high regard for safety, quality, and regulatory compliance, aligning with divisional and local site procedures.
- Support regulatory inspections and maintain proficiency in ISO 13485, ISO , and other relevant quality management systems.
Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field; advanced degree (Master's or PhD) preferred.
- Minimum of 8 years of experience in pharmaceutical, biologic, medical device, or combination product engineering, with at least 4 years managing external partners and suppliers.
- 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.
- Demonstrated technical leadership in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing, with experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
- Exceptional project management skills and strong verbal and written communication abilities; prior experience leading combination product development teams and working groups.
Additional Information
Location: West Point, PA. Travel requirements: up to 25%.
US and Puerto Rico residents only; accommodation guidance available during the application process. This role is eligible for annual bonus and long-term incentives, if applicable. Hybrid work model available; details vary by site.
Relocation: Domestic; Visa Sponsorship: Yes.
Salary range: $139,600.00 - $219,700.00. Benefits include medical, dental, vision, retirement plans (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at Merck’s compensation and benefits page.
Application notes: You can apply for this role through the Merck careers site. The posting includes information about equal employment opportunity and accommodations for applicants as required by law.
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