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. 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 […]
Senior Quality Technician
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Inspect/test components as part of incoming inspection. Use common QC inspection tools such as micro-balances, calipers/micrometers, pin gages, rulers, thickness gages, thermometers, timers, vacuum/pressure gages, optical measurement machines Perform quality review of Lot History Files (LHRs) Maintain files for equipment requiring validation, calibration […]
Principal Regulatory Affairs Specialist
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the company’s strategic objectives Formulate and implement regulatory strategy, provide guidance, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet […]
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 […]