<p>Position Summary</p> <p>You will lead and support product and process development project activities related to Fresenius Medical Care fluid products, including parenteral solutions and dialysate concentrate fluid products. This is a newly created position to support growth in Fresenius Medical Care unique portfolio of dialysis fluid offerings.</p> <p>Specific Duties</p> <ul> <li> <p>Lead?major projects, or phases of projects, to resolve advanced and complex technical problems.</p> </li><li> <p>Lead product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.</p> </li><li> <p>Lead product-sustaining projects related to product design improvements for reliability improvement, cost reduction, usability, meeting standards, manufacturability, or others.</p> </li><li> <p>Support design transfer activities between the development team and Fresenius Medical Care manufacturing facilities or 3rd party contract manufacturers</p> </li><li> <p>Work with and support Quality Assurance and Research and Development teams to maintain an approved Quality System that complies with GMPs, QSR, and ISO standards.</p> </li><li> <p>Work with and support supply chain projects and activities related to maintaining production and on-time deliveries of NxStage dialysis fluid products.</p> </li><li> <p>Domestic and international traveling (on an as-needed basis, up to 20% of total time)</p> </li></ul> <p>Education, Qualifications & Experience</p> <ul> <li> <p>BS in Engineering or Chemistry with 8+ years of experience in product design or manufacturing of parenteral solutions</p> </li><li> <p>Project Management Certification (PMP) strongly preferred</p> </li><li> <p>MS or MBA preferred</p> </li><li> <p>Experience with ISO 13485, ISO 10993, ISO 14971, and ISO 11607 preferred</p> </li><li> <p>Experience with ISO 13408 Aseptic Processing a plus</p> </li><li> <p>Strong understanding of product and process development of medical devices required with experience in parenteral drugs (USP/EP/BP)?preferred</p> </li><li> <p>Familiarity with analytical methods, stability study design (ICH Q1A), and microbial testing desirable</p> </li><li> <p>Positive can-do attitude and strong leadership skills</p> </li><li> <p>Ability to work in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals</p> </li><li> <p>Excellent interpersonal skills with the ability to fluently communicate technical concepts to all levels within the organization</p> </li><li> <p>Ability to manage complexity in a fast-paced environment</p> </li><li> <p>Advanced understanding of the entire development process, including specification, documentation, and quality assurance</p> </li><li> <p>Experience working with contract manufacturers and suppliers, including outside the United States</p> </li></ul> <p>Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.</p>