Sr. Project Engineer- Fluids

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
  
  
  

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.

EOE, disability/veterans