Packaging Engineer 3

Job description

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 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. 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 non‑sterile 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, e‑beam, 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 & Cross‑Functional Collaboration • Work with packaging suppliers, contract manufacturers, and testing laboratories • Collaborate cross‑functionally with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Marketing • Support NPIs, design changes, and product lifecycle activities Your Profile • Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, or related discipline • 3–7 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 problem‑solving skills • Bilingual English / Spanish (excellent English communication skills required) • Lean / Six Sigma or continuous improvement experience preferred • Detail‑oriented, analytical, and risk‑based thinking • Ability to manage multiple projects and priorities • Hands‑on 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 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