Senior Software Engineer (Medical Device)

Duration: 6 months to start

Job Description

Position Summary:

The candidate will participate in product development activities related to the design, development, testing, and/or support of software for our client s life-extending & life-saving systems.

Specific Duties

• Design, develop, code and unit test software following internal design control SOPs
• Apply state-of-the-art methods in creating software for products and develop improvements to existing designs
• 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 our client 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