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Medical Devices

Title:

Senior C# Developer / Senior Software Engineer Duration:

6-month contract with potential to extend based on performance/need. Location:

Remote position Remote position but would be a bonus if candidate is around

MA.

HOME RUN Candidate: Medical Devices. Client has a product called NxStage- it is a

Solo/independent home hemodialysis (HHD)

is an innovative option made available in 2017, when the

NxStage

systems became the first and only hemodialysis system for people who cannot get to a Hospital or Clinic.

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 & life-saving systems.

Specific Duties: • 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 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

Requirements: • B.S. Degree in Computer Science, Computer Engineering, Electrical Engineering or equiv. • 5+ years of experience as a software engineer/developer • Medical device industry experience: Class II, III device • Proficiency in C# • 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

Desired Experience: • Proficiency with WinForms • Experience with other UI Frameworks including WPF, Avalonia • 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 • Experience with remote software updates • Experience with Linux including packages and applying patches • Knowledge of Networks, Network infrastructure and Network protocols • Knowledge on Service Oriented Architecture and Microservices