Sr. Project Engineer - Fluids Disposables

Company: Fresenius Medical Care North America
Location: Lawrence
Posted on: January 17, 2023

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