Medical Devices Manufacturing Specialist

Key responsibilities include acting as a drug device combination expert.

This role involves collaborating with development teams and third-party companies during device development stages and regulatory submissions.

• Search and select new technologies, suppliers, and manufacturers for medical devices development and assembly.
• Generate Design History Files (DHF) and related documentation for medical devices.
• Author tech transfer protocols and reports for medical device manufacturing in selected facilities.

Additional tasks include scientific support during medical device development, assembly process tech transfer, and validation, as well as deviation root cause analysis and impact assessment, corrective actions, and risk assessments.