Quality Systems Specialist
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Maintain the quality system in compliance with ISO 13485, 21 CFR 820, and applicable GMP requirements, and help drive quality system improvements Maintain supplier quality system by working with cross-functional team to assess suppliers, review and update supplier files as needed, and tracking […]
Sr. Analytical Chemist
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Perform analytical chemistry research to develop robust assays based on new and existing methodologies. Develop, establish, and validate testing methods used to control raw materials, in-process/production intermediates, and final products. Establish, validate, and document new or existing compound identification methods. Conduct all laboratory […]
Production Supervisor
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Responsible for leading, planning, organizing and directing all daily activities for the Production Technicians. Assigning production tasks to employees based on their skill sets and the production requirements of the product; Cross-training matrix Track/meet productivity goals; track/meet yield goals; track/meet WIP goals Recommend […]
Manufacturing Engineer
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir. Develop new processes, optimize existing processes and systems, and design for future requirements Develop Manufacturing Engineering projects to improve quality, capacity, and cost. Lead cross-functional stakeholder groups for projects. Analyze […]
Manufacturing Technician
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Manufacture commercial, prototype, pre-clinical and clinical units in a Cleanroom Environment. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging Operate computer-controlled machinery Complete manufacturing documentation such as Lot History Records (LHR) in compliance with Good Documentation […]
Accounting Manager
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Maintain the quality system in compliance with ISO 13485, 21 CFR 820, and applicable GMP requirements, and help drive quality system improvements Maintain supplier quality system by working with cross-functional team to assess suppliers, review and update supplier files as needed, and tracking […]
Senior Manufacturing Engineer
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir. Requires detailed technical knowledge of processes and systems. Must be able to develop new processes, optimize existing processes and systems, and design for future requirements Develop Manufacturing Engineering projects to […]
Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease
Elixir Medical today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System.