SR PACKAGING ENGINEER

41037 Mirandola, Province of Modena, Italy Req #437 Monday, November 4, 2024 About Mozarc Medical At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world’s largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders. Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients’ lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical. Location: Mirandola, Modena (Hybrid) A Day in the Life Mozarc Medical’s newly created User Experience group supports all projects across the company and aims to align the areas of the projects that face the customer (design, labeling, packaging) in a single group. In this exciting role as a Sr Packaging Engineer, you will be responsible for the packaging design and validation for the Mozarc Medical family of products including dialysis catheters, dialysis devices, and accessories. This is an opportunity to help establish a new packaging team, set best practices, establish working relationships across the company, and work with a truly global team. Responsibilities may include the following and other duties may be assigned: Design, develop, and test a wide variety of packaging used for the protection, display, and handling of capital equipment, disposable products, and consumables. This includes sterile and non-sterile products. Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Manage documentation and/or coordinate Good Manufacturing Practices (GMPs) and support prototype line development in manufacturing facilities/plants. Work within a cross-functional team to develop stakeholders' needs, design requirements, and risk analysis pertaining to packaging. Assure adherence to packaging procedures, regulations, and standards. Must Have: B.S. degree in package engineering, biomedical engineering, or a related field, and a minimum of 4 years relevant experience. Knowledge in: Packaging Engineering (medical device sterile packaging design) Packaging materials & sterilization processes ISO 11607-1 & -2 Design control Managed or lead root cause analysis/CAPA Nice to Have: Excellent technical skills and knowledge of package development principles. Familiarity with industry guidelines and standards, such as USP, ASTM, ISO, and ISTA. Experience collaborating with external suppliers, contract manufacturing organizations, and contract test laboratories. Understanding of cGMP and GLP processes/standards (21 CFR Part 211). Applicable experience of packaging verification requirements for pharmaceutical product/combination products. Why Work with Us? Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes, and a renewed passion for life. It’s essential our team members feel valued, supported, and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop, and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Is this the position you were waiting for? Apply here! #J-18808-Ljbffr