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Software Development Specialis...
Software Development Specialist – Team Leader
The Software Development Specialist will lead the software development and test engineering teams, to create, test, and maintain medical device software in a fast paced, dynamic environment. The candidate will guide the software development process, while working to constantly improve efficiency and generate high quality, medical grade software output.The candidate should be detail oriented, have excellent written and verbal communications skills and be able to lead a team to enhance the re-useable design of an object-oriented code-base, improve testing capabilities, and extend technology offerings.
The candidate will maintain design control compliance for Class II regulated medical products, review project design control documentation, approve production releases and participate in customer and FDA audits, when necessary.
The candidate will work closely with project managers and the engineering teams to monitor project progress, coordinate project resources and be instrumental in establishing, reviewing and verifying that requirements are accurate, complete, unambiguous, and testable.
The candidate will assist the business development team in creating estimates for client proposals and promoting software offerings to potential clients.
Candidate will have at least 5+ years of experience in embedded software development for complex instrumentation, with experience in control technologies used on complex IVD devices. The candidate must have an in-depth understanding of state-of-the-art software technologies, including.Net, C#, SQL, C++, Linux, QT/QML, and real-time OS's. Experience in the creation of software test and validation records and compliance with medical device regulatory standards, including IEC 62304 and FDA software design controls, is a must.Working experience in an Agile development environment is desired.
Experience working with global development teams a plus (German and French).