Manufacturing Engineer

Fresenius Medical Care; Reynosa; Presencial; MXN 350.000 - 520.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care in Reynosa, Mexico is seeking a Manufacturing Engineer to develop, validate, and improve manufacturing processes for dialysis components in a highly regulated medical device environment.

You will collaborate with Manufacturing, Quality, Operations, and Engineering teams to support new product introductions, process validations, and continuous improvement initiatives, applying Lean principles and risk management.

Formación

• Bachelor's degree in a related engineering field is required.
• Experience with GMP, FDA requirements, CAPA, NC, Risk Management, and Quality Systems.
• Proficiency in SolidWorks and CAD software.

Responsabilidades

• Develop and optimize manufacturing processes for new and existing products.
• Support Product Risk Management and continuous improvement of manufacturing and Quality System processes.
• Create and maintain validation protocols, reports, GMP procedures, and ECOs per FDA requirements.
• Design manufacturing fixtures, gauges, and assembly tools using SolidWorks.
• Lead production line adjustments and support engineering studies and revalidation activities.
• Investigate validation failures and CQAs, supporting CAPAs and NC investigations.
• Evaluate process changes via DCAF, VCA, and VP assessments and implement improvements.
• Lead rework activities with protocol development, work instructions, and pFMEA documentation.
• Apply Lean tools, time and motion studies, line balancing, Pareto analysis, and process mapping.
• Support plant strategic projects, KPI tracking, customer complaint investigations, and CI initiatives.

Conocimientos

Analytical thinking

Problem solving

Communication

Lean Manufacturing

Educación

Bachelor's Degree in Industrial, Mechanical, Electronics, Mechatronics, Manufacturing Engineering, or related field

Herramientas

SolidWorks

Descripción del empleo

Manufacturing Engineer

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.

Guided by our vision- "Creating a future worth living. For patients. Worldwide. Every day."- we work with purpose and compassion, supported by a global team of over 110,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way-growing with purpose and leading kidney care with integrity and innovation

At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines, and PD cycler machines.

By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we're not only driving innovation- we're also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.

The Manufacturing Engineer is responsible for developing, validating, and continuously improving manufacturing processes that ensure product quality, operational efficiency, and regulatory compliance. This role partners closely with Manufacturing, Quality, Operations, and Engineering teams to support new product introductions, process improvements, product validations, and strategic initiatives in a highly regulated medical device environment.

The ideal candidate is passionate about problem-solving, process optimization, and implementing innovative manufacturing solutions that directly contribute to improving patient lives worldwide.

Your Responsibilities

• Develop and optimize manufacturing processes for new and existing products.
• Support Product Risk Management activities and continuous improvement of manufacturing and Quality System processes.
• Develop, execute, and maintain process validations, validation protocols, validation reports, GMP procedures, performance qualifications, and Engineering Change Orders (ECOs) in compliance with FDA and Quality System requirements.
• Create and update manufacturing documentation, including work instructions, Validation Change Assessments (VCA), Validation Plans (VP), and change control documentation (CNs/CCNs).
• Design manufacturing fixtures, poka-yokes, gauges, and assembly tools using SolidWorks.
• Lead production line adjustments and support engineering studies, process validations, and revalidation activities.
• Investigate validation failures and Critical Quality Attributes (CQAs), supporting corrective and preventive actions (CAPAs) and Non-Conformance (NC) investigations.
• Evaluate process changes through DCAF, VCA, and VP assessments and implement validated improvements.
• Lead rework activities, including protocol development, work instructions, visual aids, and pFMEA documentation.
• Apply Lean tools, time and motion studies, line balancing, Pareto analysis, and process mapping to improve manufacturing performance.
• Support plant strategic projects, KPI tracking, customer complaint investigations, and continuous improvement initiatives.

Your Profile

• 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.
• Good English communication skills preferred.
• U.S. Visa required.
• Availability to travel to the U.S. and other countries as required.

Our Offer for You

There is a lot you can discover at Fresenius Medical Care, regardless of the field of expertise or level of experience- everything is dedicated to supporting your professional journey.

• Whether in front of or behind the scenes, you help make better medicine available to more people worldwide
• Individual opportunities for self-determined career planning and professional development
• A corporate culture that encourages innovative thinking- finding the best solution together, not just the fastest one
• A team of committed professionals with diverse skills, talents, and experiences
• The strength of a successful global corporation combined with the collegial culture of a mid-sized company.