• Author and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF).


• Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle.


• Support product development and technology transfer from early development through clinical and commercial manufacturing.


• Translate user needs into functional requirements and design outputs, including support of Human Factors Engineering activities.


• Develop and support design outputs, specifications, packaging, and verification activities.


• Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.


• Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.

<...