Fresenius Medical Care
Staff Software Engineer
Fresenius Medical Care, Lawrence, Massachusetts, us, 01842
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 beyondconvenience.
Specific Duties:Lead the design, source code and test development following internal design control SOPsWork as a subject matter expert in product technology, meeting & exceeding state-of-the-artDevelop the architecture with reliability, performance, and safety in mindInstitute and train others on the principles of software configuration management, software development life cycle, and software maintainability, as applicableTroubleshoot issues using the best debug techniques available including paired programming for complex issuesCreate and maintain requirements and specification documentsAssist 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 addressedConduct code, design, and phase transition reviewsWork cross-functionally with teams, knowing when and how to facilitate communication effectivelyProvide technical support for product engineering, design development, integration, test, and evaluationCollaborate with our Quality Assurance team to meet the requirements of internal Quality System, including specific requirements of GMPs, FDA QSR, IEC and ISO standardsAssist in gathering data through mining, developing reports and other related activitiesVirtually assist in integrating NxStage Medical's products with customer systemsAssist with investigating and resolving software related customer challengesEnsure all systems and health data are protected according to relevant standards as defined in SOPsRequirements:
B.S. Degree in Computer Science, Computer Engineering, Electrical Engineering or equiv., M.S. Degree preferred10+ years of experience as a software engineer/developerAdvanced Proficiency in C# .NET and REST APIsProficiency with WinForms design and developmentCommand of Object-Oriented Design (OOD) and Object-Oriented Programming (OOP)Experience working in a regulated industryExperience in all phases of the software development lifecycleExperience with Microsoft Development ToolsExperience with Entity Framework and MSSQL or SQLKnowledge 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 writtenDesirable Experience:
Medical device industry experience: Class II, III device including FDA clearanceExperience contributing towards an automated build processExperience 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 and .NET Standard and .NET CoreExperience 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.
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 beyondconvenience.
Specific Duties:Lead the design, source code and test development following internal design control SOPsWork as a subject matter expert in product technology, meeting & exceeding state-of-the-artDevelop the architecture with reliability, performance, and safety in mindInstitute and train others on the principles of software configuration management, software development life cycle, and software maintainability, as applicableTroubleshoot issues using the best debug techniques available including paired programming for complex issuesCreate and maintain requirements and specification documentsAssist 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 addressedConduct code, design, and phase transition reviewsWork cross-functionally with teams, knowing when and how to facilitate communication effectivelyProvide technical support for product engineering, design development, integration, test, and evaluationCollaborate with our Quality Assurance team to meet the requirements of internal Quality System, including specific requirements of GMPs, FDA QSR, IEC and ISO standardsAssist in gathering data through mining, developing reports and other related activitiesVirtually assist in integrating NxStage Medical's products with customer systemsAssist with investigating and resolving software related customer challengesEnsure all systems and health data are protected according to relevant standards as defined in SOPsRequirements:
B.S. Degree in Computer Science, Computer Engineering, Electrical Engineering or equiv., M.S. Degree preferred10+ years of experience as a software engineer/developerAdvanced Proficiency in C# .NET and REST APIsProficiency with WinForms design and developmentCommand of Object-Oriented Design (OOD) and Object-Oriented Programming (OOP)Experience working in a regulated industryExperience in all phases of the software development lifecycleExperience with Microsoft Development ToolsExperience with Entity Framework and MSSQL or SQLKnowledge 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 writtenDesirable Experience:
Medical device industry experience: Class II, III device including FDA clearanceExperience contributing towards an automated build processExperience 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 and .NET Standard and .NET CoreExperience 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.