Sr. Project Engineer - Fluids Disposables - NxStage

Position Summary

You will lead and support product and process development project activities related to NxStage Medical’s fluid products including parenteral solutions and dialysate concentrate fluid products. This is a newly created position to support growth in NxStage’s 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.
• Support design transfer activities between the development team and NxStage’s 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 GMP’s, QSR and ISO standards.
• Work with and support supply chain projects and activities related to maintaining production and on-time deliveries of NxStage RFP line of 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 entire development process, including specification, documentation and quality assurance
• Experience working with contract manufacturers and suppliers, including outside the United States

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.