Associate Director, Device Technology

Job Description

Job Summary:  

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. 

Essential Duties and 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.

• Identifying issues with minimal signals, problem solving, identification of root cause 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, drive technical and programs decisions through the development team and governances

• Support responses regulatory agency questions and pre-approval inspections during a 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 needs of manufacturing are considered as part of the design.  Provide information and 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, providing support for global and site-specific projects related to combination products and drug delivery systems.

• 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.

Qualifications:

• Bachelor’s degree in mechanical engineering, Biomedical Engineer, or a related a technical field (e.g., Chemical Engineering, Materials Engineering) required; 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 in managing external partners and suppliers.

• 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 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 principled verbal and written communication abilities, and prior experience leading combination product development teams and working groups

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.  For more information about personal rights under the U.S. Equal Opportunity Employment laws,