Position Summary:  

The candidate will participate in product development activities related to the design, development, testing, and/or support of software for NxStage Medical’s life-extending & lifesaving systems. At NxStage, we’ve seen first-hand how patients have enjoyed improved health and a better quality of life through more frequent home dialysis whether HHD or PD. But don’t take our word for it. Many studies have shown that the benefits of home dialysis go far beyond
convenience.

Specific Duties: 

Design, develop, code and unit test software following internal design control SOPsApply state-of-the-art methods in creating software for NxStage products and develop improvements to existing designsApply the principles of software configuration management, software life cycle, and software maintainability, as applicableDebug new designs and develop reliability improvements to existing & new designsConduct code reviews, create and maintain requirements and specification documentsCreate and execute unit tests as part of software validation effortsParticipate in multidisciplinary teams, including pairing with other engineers to solve complex problemsProvide technical support for product engineering, design development, integration, test, and evaluationFollow Design Control SOPs for projects and programs, including following the software development lifecycleWork with Quality Assurance to meet the requirements of our internal Quality System, including specific requirements of GMPs, FDA QSR, relevant IEC standards, and ISO 9001Assist in Risk Analysis including, Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressedAssist in developing reports and other data mining activitiesAssist in Integrating NxStage Medical’s products with customer systemsAssist with researching and resolving software related customer complaintsEnsure all systems and data are protected according to relevant SOPs

Education & Qualification: 

BS in Computer Science with a focus on software design and programming.7+ years of experience in software product engineering and development.

Requirements: 

B.S. Degree in Computer Science, Computer Engineering, Electrical Engineering or equiv.5+ years of experience as a software engineer/developerProficiency in C#, and WinForms designExperience working in a highly regulated industryExperience in all phases of the software development lifecycleExperience with Microsoft Development Tools ● Experience with Entity Framework and MSSQL or SQLKnowledge of Object Oriented Design (OOD) and Object-Oriented Programming (OOP)Knowledge of project lifecycles, software development environments, and source control techniquesKnowledge of code versioning systems such as Git, SVN, and MercurialKnowledge of cybersecurity methodologies and testingEffective team communication skills including verbal and written

Desirable Experience:

Medical device industry experience: Class II, III deviceExperience with automated testingExperience creating, deploying, and managing Windows Embedded Systems using WinPEExperience in building solutions using MS Azure technologiesExperience in Web UI design using Angular, React, or JavaScript / jQuery, HTML, and CSSExperience with .Net Core and REST APIsExperience with Cloud-based Web Service like Azure or AWSExperience with cybersecurity methodologies and testingExperience with Git and Azure DevOpsKnowledge of Networks, Network infrastructure and Network protocolsKnowledge on Service Oriented Architecture and Microservices

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.