Senior Principal Combination Product Quality Engineer

Biogen is seeking a seasoned Senior Principal Combination Product Quality Engineer to serve as an Associate Director within our Quality, Combination Products, and Devices team. In this role, you will provide comprehensive quality oversight for the lifecycle management of combination products. Your expertise in design control, risk management, and human factor engineering will drive continuous improvement efforts and ensure compliance with local and global regulations. You will play a critical role in shaping our design and development processes, contributing to regulatory strategies, and managing external partnerships.

What You’ll Do:

• Provide Subject Matter Expertise in combination products, guiding quality engineering function on related issues.
• Lead the execution of Design Control processes across all stages of product development.
• Ensure compliance with global quality standards by reviewing and approving technical documentation.
• Guide R&D and manufacturing design processes to implement effective Design Control principles.
• Manage external relationships with device suppliers and testing partners, ensuring adherence to quality standards.
• Spearhead continuous imp...