Position Specific Information
NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities
As a key member of the Software Design Assurance Group, the incumbent will support the activities related to the design, development, and ongoing maintenance of software-based medical device products and supporting software.
Provides quality oversight and guidance for software design and development, for product and non-product software.
•Review deliverables of the development lifecycle for correctness and compliance to policies.
•Lead major efforts, or phases of projects, to resolve Software Quality-related problems
•Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed
•Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies
•Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities
•Investigate/reproduce customer problems/issues
•Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001