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Sr. Project Engineer - Fluids Disposables - NxStage


Lawrence, Massachusetts

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Job ID R0018980

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.

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