Manufacturing Engineer
$31,200–$31,200 year
On-siteReynosa, Tamaulipas, Mexico
Job Summary
Develop and optimize manufacturing processes for new and existing dialysis products while supporting product risk management and continuous improvement. Execute and maintain process validations, GMP procedures, and Engineering Change Orders in compliance with FDA and Quality System requirements. Create manufacturing documentation, design fixtures and assembly tools using SolidWorks, and lead production line adjustments. Investigate validation failures and critical quality attributes to support corrective and preventive actions. Apply Lean tools, time and motion studies, and process mapping to improve manufacturing performance and support plant strategic projects. This role partners closely with Manufacturing, Quality, Operations, and Engineering teams within Fresenius Medical Care's Reynosa plant to drive innovation and efficiency in dialysis product manufacturing.
Required Qualifications
- Bachelor's Degree in Industrial, Mechanical, Electronics, Mechatronics, Manufacturing Engineering, or related field
- Experience or knowledge in manufacturing processes, process validation, and continuous improvement
- Knowledge of GMP, FDA requirements, CAPA, NC, Risk Management, and Quality Systems
- Experience with Lean Manufacturing, line balancing, time and motion studies, and basic statistics
- Proficiency in SolidWorks or similar CAD software
- Strong analytical, problem-solving, and communication skills
- Proficiency in Microsoft Office applications
- U.S. Visa required
- Availability to travel to the U.S. and other countries as required
Desired Qualifications
- Good English communication skills preferred
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