Principal Manufacturing Engineer - Implantable Device Unit

About This Role:

As a Principal Manufacturing Engineer, you will be an integral part of the Implantable Device Unit and Device Development and Manufacturing team, within the Product Delivery Solutions organization. Your primary responsibility will be to drive manufacturing strategies and execution for Class III implantable drug delivery systems. This role is essential in shaping and advancing scalable and compliant manufacturing approaches throughout the product lifecycle, from development through commercialization. As a recognized subject matter expert, you will influence cross-functional decisions, establish best practices, and drive continuous improvement within the organization. You will also lead external engagement with contract manufacturers and industry forums to benchmark and implement leading practices. Your contributions will be pivotal in ensuring the success of our manufacturing processes and aligning them with broader organizational objectives.

What You’ll Do:

• Lead end-to-end manufacturing strategy, scale-up, and lifecycle management, ensuring alignment with program and organizational objectives.
• Define and implement manufacturing standards, control strategies, and best practices across IDU programs.
• Serve as the primary technical authority with contract manufacturers, driving performance and innovation.
• Influence cross-functional and organizational decisions, providing SME input to development, quality, regulatory, and supply chain strategies.
• Drive manufacturing technology roadmaps, process innovation, and continuous improvement initiatives.
• Represent the organization externally through industry engagement and collaboration to bring in leading practices.
• Transfer new product designs into scalable and robust manufacturing processes.
• Establish inspection strategies, validation plans, and compliance documentation.
• Evaluate suppliers, manage contract manufacturers, and optimize supply chain processes.
• Select and optimize manufacturing processes, tooling, and assembly approaches.
• Approve routine engineering documentation and resolve day-to-day manufacturing issues.

Who You Are:

You are a strategic thinker with a passion for innovation and excellence in manufacturing. Your extensive experience in the medical device industry, particularly with Class III implantable devices, has equipped you with a deep understanding of complex manufacturing processes. You thrive in a collaborative environment, working cross-functionally to drive strategic partnerships and continuous improvement. Your ability to influence decisions and lead technical engagements externally is matched by your commitment to maintaining compliance with stringent regulatory requirements. You have a keen eye for detail and a proactive approach to troubleshooting and optimizing manufacturing processes.

Required Skills:

• Bachelor’s in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a closely related discipline.
• 10+ years of manufacturing engineering experience in medical devices.
• Experience with Class III implantable devices and/or drug delivery systems.
• Demonstrated experience in manufacturing scale-up, process validation, and commercialization.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements.
• Experience in leading cross-functional teams and managing external partnerships.
• Proficiency in developing and implementing manufacturing technology roadmaps.
• Strong problem-solving and troubleshooting skills in multi-component assemblies.