Material Project Leader

Job Description Summary

For more than 125 years, we have pursued our purpose by driving the world of health™. We are relentlessly committed to a promising future through the development of innovative technologies, services, and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD-from manufacturing to marketing our products-to see the impossible and find transformative solutions that turn our dreams into possibilities-for people today, tomorrow, and in the future.

By aligning and streamlining our work, our Integrated Diagnostic Solutions (IDS) business unit aims to drive growth and innovation in everything from integrated sample management to diagnostic solutions. The Integrated Diagnostic Solutions (IDS) unit is currently seeking:

Responsible for leading and coordinating supplier change projects related to materials, processes, and product design, ensuring implementation in compliance with established quality standards, timelines, and regulatory requirements.

Job Description

Functions and Responsibilities

• Provide leadership and direction to all disciplines involved to ensure supplier change requests related to materials, processes, and product design meet project goals.
• Coordinate cross-functional areas to ensure timely completion of deliverables required by change control.
• Ensure project management complies with Quality System procedures and applicable division standards.
• Develop project timelines, supply plans, and risk management strategies, and communicate risks to stakeholders and management.
• Interact with internal and external functions such as Supplier Quality, Manufacturing, Operations, R&D, Regulatory Affairs, and Division Quality to assess the impact of changes.
• Track supplier validation activities, inventory buildup, and inventory control to implement changes into regular production.
• Lead product line and process changes from suppliers and sister BD plants, coordinating cross-functional efforts in materials, quality, documentation, process engineering, production, and finance.
• Ensure compliance with procedures, manage deliverables through team meetings and phase reviews, resolve issues during transfers, and manage project risks.
• Manage engineering documentation including supplier IQ/OQ/PQ, SPO runs, specification updates, BOM changes, and process modifications.
• Coordinate and track R&D testing to ensure compliance with validation requirements (sterilization, biocompatibility, product stability).
• Collaborate with Planning and Purchasing to manage material depletion, service impact analysis, and role changes.
• Lead internal and external meetings, document discussions, and follow up on open actions related to SIB projects.
• Provide daily/weekly project updates to stakeholders and escalate supply-related risks to upper management.
• Maintain the Reynosa Impacted Supplier Change Request (SCR) database in the BD portal.
• Propose continuous improvements to materials and supply processes.
• Actively participate in the development of manufacturing and documentation processes for new products (BOMs and specifications).
• Travel occasionally to the U.S. to support project progress and completion.
• Execute other tasks assigned by the supervisor, aligned with the business's strategic priorities and needs.

• BSE.
• 3 years in product/equipment transfers and validation process; manufacturing background; medical industry experience (preferred).

• Bilingual English and Spanish. Proficiency in general, computer skills (MS Project, MS Office, Windows).
• Minitab Statistical basic knowledge (desired).
• Leadership and initiative are critical.
• Good communication skills.
• Dynamic, positive attitude with good interpersonal and organizational skills, proficient, ability to work under pressure, ability to solve problems, responsible, high initiative, strong leadership.