Plastics Engineer I

Plastics Engineer I

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 day.we 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.

As a Plastics Engineer I you will validate new systems and maintain the validated state of existing systems used to manufacture components tubing and resins in the plastics area. You may also support cost-saving projects process improvements and cross-functional validation/engineering addition you will coordinate review and evaluate the work of plastics engineering technicians.

Responsibilities:

• Lead engineering project implementations in the molding area coordinating activities to meet schedule commitments.
• Maintain 100% training compliance per the applicable curriculum.
• Follow and ensure compliance with current GMP and documentation practices keeping local procedures updated and compliant.
• Identify and verify machine/peripheral equipment manuals drawings and dimensional reports for protocol development.
• Develop and execute equipment validation protocols (IQ/OQ).
• Develop and execute engineering studies per task/project by defining tests that challenge physical/mechanical characteristics per specifications/drawings; document per established procedures.
• Support training and execution/verification of physical test methods from method design through release.
• Perform and verify periodic process/equipment reviews in a timely manner and document per effective procedures.
• Support Engineering on implementation innovation new equipment development and improvements.
• Reconcile material generated during engineering study and validation runs.
• Maintain scan and archive physical validation/study documentation and peripheral equipment manuals.
• Keep the validation list updated per current validation procedures.
• Support development of detailed modules/instructions for specific manufacturing process tasks.
  Perform annual reviews temporary deviations and activities related to engineering project implementation.
• Create Change Control Notifications (CCN) and required supporting documentation for process/support document updates.
• Create Document Management Change (DMC) for administrative updates and organizational chart revisions.
• Train Plastics and Quality personnel prior to executing validation protocols engineering changes/module creation and procedure changes.

Qualifications:

• Engineering degree (Industrial preferred).
• 2 years of experience in IQ/OQ/PQ validation schemes.
• 2 years generating executing and reporting engineering studies.
• 1 year developing modules engineering changes and temporary process deviations.
• Medical industry experience desirable; plastics area experience desirable.
• 1 year using basic measurement devices (caliper micrometer etc.).
• Continuous improvement tools experience (Ishikawa 5 Whys DMAIC etc.).
• Strong computer skills required; SPC experience preferred.
• Intermediate MS Office; Minitab Visio Project.
• Bilingual (English/Spanish).

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