This role partners cross-functionally with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Program Management to drive quality-focused decision making, risk-based development practices, and efficient execution of development programs. The Senior Manager establishes and maintains Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.

Key responsibilities include:

+ Establish and maintain Design Assurance processes, tools, and governance supporting compliant and efficient product development.

+ Provide strategic and tactical quality leadership across new product development, sustaining engineering, and design change activities.

+ Ensure effective implementation of Design Controls, Risk Management, Verification & Validation, usability engineering, and design transfer requirements.

+ Drive quality awareness, visibility, and communica...