Manufacturing Engineer

Manufacturing Engineer Date: 18 Jan 2024 Location: Athens State: TX Country: US Company: LTTS ESSENTIAL DUTIES AND RESPONSIBILITIES • Lead new product introductions and ensure successful transition to manufacturing • Provide manufacturing engineering support for the development and manufacturing of new products • Evaluate proposed designs for manufacturability and provide DFM recommendations • Develop and establish robust, repeatable, and reproducible processes • Represent manufacturing engineering in cross-functional teams • Perform process validations (IQ/OQ/PQ) • Monitor, evaluate and report project progress and results • Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis • Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality • Prepare technical and validation protocols, written reports, documentation, and engineering change notifications • Provides technical supplier management support as related to product development and introduction • Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and workspace for maximum efficiency.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards • Estimate production times, staffing requirements, and related costs to provide information for management decisions.
• Confer with management, engineering, and other staff regarding production capabilities, production schedules, and other considerations to facilitate production processes • Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations LEADERSHIP RESPONSIBILITIES • Lead functional and cross-functional teams to achieve project goals.
• Mentor junior manufacturing engineers in project management activities EDUCATION AND/OR EXPERIENCE • Bachelor’s Degree or higher in biomedical, mechanical, industrial or similar discipline • Minimum of five (5) years related experience in FDA/GMP regulated industry.
• Proficient in SolidWorks, Minitab, Word, Excel and Project • Experience in product development and manufacturing methods, procedures, and cost reduction/yield improvement techniques • Background in medical device assembly, automation, and vision system technology • Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required • Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ) Nearest Major Market: Tyler