Vacancy caducado!
- Develop and support all aspects of manufacturing for both clinical investigational products as well as clinical commercial products including but not limited to biomaterials and combination products
- Involved in the direct manufacturing of bio-absorbable medical devices
- Hands-on chemical synthesis of bio-absorbable medical devices
- Responsible for the development and reviewing of SOP's (Standard Operation Procedures), Manufacturing Instructions as well as Manufacturing Batch/Device History Records
- Involvement in vendor relations for procurement and installation
- Involved in the development, design and analysis of the Design of Experiments
- Develop, author and implement safe manufacturing operations processes and procedures including the safe handling of raw materials, processes and products
- Strong engineering skills
- Willingness to learn new skills in the medical device and or combination device manufacturing process
- Ability to perform manufacturing operations in clean rooms producing medical devices and combination products that include chemical processing
- Ability to perform chemical reactions and polymer processing
- Statistical analysis skills are strongly preferred
- Proficiency in MS Office tools (Outlook, Word, Excel & Miniab)
- Excellent communication skills, both written and verbal
- Knowledgeable of FDA Good Manufacturing Practices (GMP) regulations is preferred
Vacancy caducado!