Sr. Project Engineer - Fluids Disposables
Company: Fresenius Medical Care North America
Location: Lawrence
Posted on: January 17, 2023
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Job Description:
Position SummaryYou 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.DutiesLead major projects, or phases of projects, to
resolve advanced and complex technical problemsLead 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 manufacturersWork 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 &
ExperienceBS in Engineering or Chemistry with 8+ years of
experience in product design or manufacturing of parenteral
solutionsProject Management Certification (PMP) strongly
preferredMS or MBA preferredExperience with ISO 13485, ISO 10993,
ISO 14971 and ISO 11607 preferredExperience with ISO 13408 Aseptic
Processing a plusStrong understanding of product and process
development of medical devices required with experience in
parenteral drugs (USP/EP/BP) preferredFamiliarity with analytical
methods, stability study design (ICH Q1A) and microbial testing
desirablePositive can do attitude and strong leadership
skillsAbility to work in a team setting with demonstrated
experience working cross-functionally and leading teams to
accomplish goalsExcellent interpersonal skills with the ability to
fluently communicate technical concepts to all levels within the
organizationAbility to manage complexity in a fast paced
environmentAdvanced understanding of entire development process,
including specification, documentation and quality
assuranceExperience working with contract manufacturers and
suppliers, including outside the United StatesEO/AA Employer:
Minorities/Females/Veterans/Disability/Sexual Orientation/Gender
IdentityFresenius Medical Care North America maintains a drug-free
workplace in accordance with applicable federal and state laws.
Keywords: Fresenius Medical Care North America, Lawrence , Sr. Project Engineer - Fluids Disposables, Other , Lawrence, Massachusetts
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