Director – Combination Product Commercialization

Director – Combination Product Commercialization

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineer, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master’s or PhD) preferred.
• Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a leadership or management role.
• 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 prior experience leading combination product development teams and working groups.

Responsibilities

• Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.
• Develop and execute strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
• 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 compliance with 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 development standpoint.
• Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders 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.
• 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.
• Facilitate the professional development and performance of team members, fostering a collaborative and innovative team environment.
• 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.

Preferred Qualifications

• advanced degree (Master’s or PhD) preferred