Job Information
Fresenius Medical Care North America Staff Software Engineer in Lawrence, Massachusetts
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
Fresenius Medical Care North America
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