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:

• Lead the design, source code and test development following internal design control SOPs

• Work as a subject matter expert in product technology, meeting & exceeding state-of-the-art

• Develop the architecture with reliability, performance, and safety in mind

• Institute and train others on the principles of software configuration management, software development life cycle, and software maintainability, as applicable

• Troubleshoot issues using the best debug techniques available including paired programming for complex issues

• Create and maintain requirements and specification documents

• Assist in Risk Analysis including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities to ensure potential shortcomings are identified and appropriately addressed

• Conduct code, design, and phase transition reviews

• Work cross-functionally with teams, knowing when and how to facilitate communication effectively

• Provide technical support for product engineering, design development, integration, test, and evaluation

• Collaborate with our Quality Assurance team to meet the requirements of internal Quality System, including specific requirements of GMPs, FDA QSR, IEC and ISO standards

• Assist in gathering data through mining, developing reports and other related activities

• Virtually assist in integrating NxStage Medical’s products with customer systems

• Assist with investigating and resolving software related customer challenges

• Ensure all systems and health data are protected according to relevant standards as defined in SOPs

Requirements:

• B.S. Degree in Computer Science, Computer Engineering, Electrical Engineering or equiv., M.S. Degree preferred

• 10+ years of experience as a software engineer/developer

• Advanced Proficiency in C# .NET and REST APIs

• Proficiency with WinForms design and development

• Command of Object-Oriented Design (OOD) and Object-Oriented Programming (OOP)

• Experience working in a 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 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 including FDA clearance

• Experience contributing towards an automated build process

• 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 and .NET Standard and .NET Core

• 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