Manufacturing Engineer

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 110000 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 waygrowing 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 3000 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 were not only driving innovationwere 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

Bachelors 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 experienceeverything 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 selfdetermined career planning and professional development
A corporate culture that encourages innovative thinkingfinding 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 midsized company.