Associate Director, Device Tech Transfer

Job Description

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, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate 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, and quality and regulatory compliance.

Essential Duties and Responsibilities:

Program Leadership and Technical Project Management:

• Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination productsglobally.

• 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. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.

Technical Expertise:

• 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 compliancewith relevant regulatory standards.

• Ensure robust technical plans, risk communication, drive technical and programs 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 developmentstandpoint

Stakeholder Collaboration and Communication:

• Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to keystakeholders and sponsors.

• 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

Regulatory Compliance and Quality Assurance:

• Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisionaland local site procedures.

• Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems.

Qualifications:

Education

Required | Technical BS degree or higher

Preferred | BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

Experience

• 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 componentmanufacturing, 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 ofquality management systems and regulatory compliance.

• Exceptional project management skills and principled verbal and written communication abilities, and experience collaborating with combinationproduct 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

Preferred Skills:

Current Employees apply