Senior Manufacturing Engineer (Laser Welding)

Job Overview Senior Manufacturing Engineer – Aquabeam Robotic System. Your mission is to establish engineering technologies for the operations team to become best‑in‑class manufacturers of medical devices and equipment. Responsibilities Lead engineering support to manufacturing and resolve issues related to process and equipment (troubleshoot existing manufacturing processes, fixtures, tooling or equipment). Develop training programs for operators and engineers. Help define the technology and equipment roadmap for medical device technologies. Champion continuous improvement by identifying projects to create and support best‑in‑class lean manufacturing systems to maximize yield, capacity, and capability. Identify, justify and implement multiple significant Design for Manufacturability (DFM) projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability. Design and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards. Maintain process documentation, including Manufacturing Instructions, Standard Works documents, PFMEA, Standard Works and Control Plans. Work with R&D and Process Development teams to develop welding schedules for transfer of new products into commercial manufacturing, both in‑house and at contract manufacturers. Identify, define, and execute new technical projects that improve manufacturing processes – including developing the scale, scope and ROI. Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield. Provide engineering support to outside suppliers and contract manufacturers, ensuring quality and production targets are met. Train, develop, and/or provide work direction to operators and technicians. May require up to 20% travel, domestic and international. Required Qualifications BS in an engineering discipline such as welding, mechanical or electrical engineering with a minimum of 5 years’ experience or an MS in engineering with a minimum of 3 years’ experience. Extensive experience with root cause analysis and problem solving for both technical and process issues. Experience working in a structured design process such as ISO9000 or FDA QSR, and knowledge of regulatory approval process and requirements. Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485‑2003 or ISO9001 and EN46001. Basic working knowledge of CAD (SolidWorks or other) software. Preferred Qualifications Recognized as a subject matter expert in process technologies such as laser cutting, welding, brazing, and joining. Experience supporting medical device manufacturing. Experience leading highly technical projects in a cross‑functional environment both internally and with CMOs/Vendors. Preferred experience with Lean and Six Sigma tools. Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks. #J-18808-Ljbffr