Packaging Engineer 3

Packaging Engineer 3

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 Packaging Engineer 3 you will be responsible for the design development qualification and continuous improvement of packaging systems for medical devices. This role ensures packaging solutions protect product integrity maintain sterility where applicable and comply with global regulatory requirements while supporting efficient manufacturing and supply chain operations.

Your Responsibilities

Packaging Design & Development Design and develop primary secondary and tertiary packaging solutions for sterile and nonsterile medical devices
Select and qualify packaging materials (trays pouches cartons labels) based on product requirements sterilization methods and distribution conditions
Create technical packaging specifications drawings and bills of materials

Validation & Compliance Plan and execute packaging validations in accordance with ISO 11607 including package integrity sealing and transportation testing
Support sterilization compatibility studies (EtO gamma ebeam steam)
Author and review validation protocols reports and supporting documentation

Regulatory & Quality Support Ensure compliance with FDA 21 CFR 820 ISO 13485 EU MDR and internal SOPs
Participate in risk management activities (ISO 14971)
Support internal and external audits inspections and design reviews

Manufacturing & Operations Support Provide technical support related to packaging equipment sealing processes and line setups
Lead investigations and root cause analysis related to packaging nonconformances or complaints
Drive continuous improvement initiatives focused on quality cost reliability and sustainability

Supplier & CrossFunctional Collaboration Work with packaging suppliers contract manufacturers and testing laboratories
Collaborate crossfunctionally with R&D Quality Regulatory Affairs Manufacturing Supply Chain and Marketing
Support NPIs design changes and product lifecycle activities

Your Profile

Bachelors degree in Packaging Engineering Mechanical Engineering Materials Science or related discipline
37 years of packaging engineering experience in a medical device or regulated manufacturing environment
Strong working knowledge of ISO 11607 FDA QSR / 21 CFR 820 ISO 13485
Experience with packaging validation seal integrity testing and distribution simulation
Experience with sterile barrier systems and sterilization processes (EtO radiation steam)
Familiarity with packaging equipment (heat sealers pouching systems tray sealers)
Strong documentation technical writing and problemsolving skills
Bilingual English / Spanish (excellent English communication skills required)
Lean / Six Sigma or continuous improvement experience preferred
Detailoriented analytical and riskbased thinking
Ability to manage multiple projects and priorities
Handson manufacturing mindset and ability to work in cleanroom or controlled environments
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