• Principal Software Engineer

    Fresenius Medical Center (Waltham, MA)


    Position Summary:

    The candidate will participate in product development activities related to the design, development, testing, and/or support of web-based software for NxStage Medical’s products.

    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; develop improvements to existing designs.

    + Apply the principles of software design, software life cycle, and software maintainability, as applicable.

    + Debugging new designs and developing reliability improvements to existing & new design

    + 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.

    + 10+ years of experience in software product engineering and development.

    Requirements:

    + Experience in all phases of the software development lifecycle.

    + Experience in microservices design and implementation

    + Experience in OOD/OOP and multi-tiered business logic implementation.

    + Experience in building Restful API application using MS Azure technologies

    + C#, .Net Core, and SQL Language Skills.

    + Experience in Web GUI design

    + Outstanding verbal and written communication skills.

    + Experience with Microsoft Development Tools.

    + Conduct code reviews, create and maintain requirements and specification documents

    + Create and execute unit tests as part of software validation efforts

    + Strong knowledge of project lifecycles, software development environments, and source control techniques.

    Desirable:

    + Familiar with Azure Cloud Technologies such DevOps, Kubernetes, Service Bus, CI/CD pipelines

    + Familiar with Identity management technologies (e.g. Entra ID) and distributed cache (e.g. Redis)

    + Experience working in a highly regulated industry, medical device preferred.

    + Experience and knowledge of cybersecurity methodologies and testing

    + Experience with automated testing.

    + Knowledge of Networks, Network infrastructure and Network protocols

     

    If your location allows for pay/benefit transparency, please click the link below to request further information on this position: https://app.smartsheet.com/b/form/c36f09ba8dc54692af34ee3a3dbd3716

     

    EOE, disability/veterans