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 […]
Principal Analytical Chemist
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Initiate, direct, and execute all scientific research and/or development strategies in research and/or development Investigate the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products, and problems Perform analytical testing to determine total content, assay, residual solvents, […]
Principal Quality Engineer
Major Duties and Responsibilities Responsibilities include: Support new product development projects to include the following: Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control. Provide Quality Engineering leadership and support for commercial medical device production: Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending, change control, and deviation […]
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.