Manufacturing Engineer

Athens, TX

About the position

Lead and participate in creating, finding, and evaluating better and more efficient ways to manufacture product and provide ongoing production support for Argon Medical products and manufacturing sites. Effectively manage and communicate progress towards project goals to management.

Responsibilities

• Provide engineering support for the development and manufacture of Argon Medical Device products.
• Evaluate proposed designs for manufacturability.
• Develop and establish robust and repeatable processes and perform process validations (IQ/OQ/PQ).
• Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality and reliability.
• 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.
• Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
• Identify, recommend, and implement upgrades and automation of current equipment.

Requirements

• Bachelor’s (or advanced) degree in biomedical, mechanical, industrial, or similar engineering discipline required.
• Minimum of 3+ years related experience in FDA/GMP regulated industry required.
• Proficient in 3D Modeling; 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).