Position Summary

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.

Specific Duties

• Lead major projects, or phases of projects, to resolve advanced and complex technical problems.

• Lead product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.

• Lead product-sustaining projects related to product design improvements for reliability improvement, cost reduction, usability, meeting standards, manufacturability, or others.

• Support design transfer activities between the development team and Fresenius Medical Care manufacturing facilities or 3rd party contract manufacturers

• 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.

• Work with and support supply chain projects and activities related to maintaining production and on-time deliveries of NxStage dialysis fluid products.

• Domestic and international traveling (on an as-needed basis, up to 20% of total time)

Education, Qualifications & Experience

• BS in Engineering or Chemistry with 8+ years of experience in product design or manufacturing of parenteral solutions

• Project Management Certification (PMP) strongly preferred

• MS or MBA preferred

• Experience with ISO 13485, ISO 10993, ISO 14971, and ISO 11607 preferred

• Experience with ISO 13408 Aseptic Processing a plus

• Strong understanding of product and process development of medical devices required with experience in parenteral drugs (USP/EP/BP) preferred

• Familiarity with analytical methods, stability study design (ICH Q1A), and microbial testing desirable

• Positive can-do attitude and strong leadership skills

• Ability to work in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals

• Excellent interpersonal skills with the ability to fluently communicate technical concepts to all levels within the organization

• Ability to manage complexity in a fast-paced environment

• Advanced understanding of the entire development process, including specification, documentation, and quality assurance

• Experience working with contract manufacturers and suppliers, including outside the United States