Position Overview
Roles & Responsibilities :
- 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 developmen...