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 SOPs
• Apply state-of-the-art methods in creating software for NxStage products and develop improvements to existing designs
• Apply the principles of software configuration management, software life cycle, and software maintainability, as applicable
• Debug new designs and develop reliability improvements to existing & new designs
• Conduct code reviews, create and maintain requirements and specification documents
• Create and execute unit tests as part of software validation efforts
• Participate in multidisciplinary teams, including pairing with other engineers to solve complex problems
• Provide technical support for product engineering, design development, integration, test, and evaluation
• Follow Design Control SOPs for projects and programs, including following the software development lifecycle
• Work with Quality Assurance to meet the requirements of our internal Quality System, including specific requirements of GMPs, FDA QSR, relevant IEC standards, and ISO 9001
• Assist 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 addressed
• Assist in developing reports and other data mining activities
• Assist in Integrating NxStage Medical’s products with customer systems
• Assist with researching and resolving software related customer complaints
• Ensure 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/developer
• Proficiency in C#, and WinForms design
• Experience working in a highly regulated industry
• Experience in all phases of the software development lifecycle
• Experience with Microsoft Development Tools ● Experience with Entity Framework and MSSQL or SQL
• Knowledge of Object Oriented Design (OOD) and Object-Oriented Programming (OOP)
• Knowledge of project lifecycles, software development environments, and source control techniques
• Knowledge of code versioning systems such as Git, SVN, and Mercurial
• Knowledge of cybersecurity methodologies and testing
• Effective team communication skills including verbal and written

Desirable Experience:

• Medical device industry experience: Class II, III device
• Experience with automated testing
• Experience creating, deploying, and managing Windows Embedded Systems using WinPE
• Experience in building solutions using MS Azure technologies
• Experience in Web UI design using Angular, React, or JavaScript / jQuery, HTML, and CSS
• Experience with .Net Core and REST APIs
• Experience with Cloud-based Web Service like Azure or AWS
• Experience with cybersecurity methodologies and testing
• Experience with Git and Azure DevOps
• Knowledge of Networks, Network infrastructure and Network protocols
• Knowledge 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.