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.
- 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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