CH - Lausanne
Design, develop, and document software applications and embedded software for Contrast Media devices. Participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing.
- Setup testing platform, issues Investigations, root cause analysis, Bug Correction and wsustaining activities. Continuous improvement of software quality, reliability and safety.
- Specify, design, develop, code, master the software release and maintain the software for the BINJ products,
- Collaborate with internal and external software teams for development, integration of our product with other software solutions
- Author, improve or review software documentation (including specifications, design and verification documents) by focusing on quality, reliability and safety of BINJ software products, as well as compliance with relevant standards (IEC62304, FDA Guidelines),
- Participate to verification and validation effort, ensure efficient, robust and high coverage test strategy
- Report and provide workload estimations
- Provide last level customer support, and propose solution to customer complaints
- Proficiency in C, C++, C# / VB .Net, SQL with expertise in multitasking, multithreading, object oriented programming,
- Relevant experience in Real Time Systems, Embedded targets, RTOS
- Relevant experience in windows technologies, .NET framework, windows drivers model, WPF, Winforms, WCF
- Relevant experience in software development and modular architecture design (UML, SOA, design patterns)
- Relevant experience in Source version control (GIT), Continuous integration (Jenkins, Teamcity), Bug tracking systems, Unit testing frameworks (CppUnit, NUnit,, LDRA),
- Experience with automated testing frameworks,
- Strong documentation and writing skills and ability to follow Quality and Regulatory requirements, prepare DHF and Technical Files
- Fluent in French and English
- 4 years of experience in either aerospace, defense or medical device environment.
- Knowledge in SW dev processes according Medical Devices Regulation and standards in US and EU
- Experience with designing software products in an FDA or other regulated industry
- Understand Change Control, Design Control and Software Development Life Cycle management
- Familiar with concepts of design input, design output, traceability and risk analysis
- Experience with class II or III medical devices and/or with medical software standards (i.e. IEC 62304 & FDA related guidance) is a big plus
- Experience or Knowledge in Windows Embedded based applications (WINDOWS CE 5.0, Windows 7 Embedded, Windows 10 IoT)
- Experience working with software methodologies (Waterfall, VCycle or Agile)
- Knowledge of automated testing frameworks and tools vstest, Python, PowerShell or other scripting languages
- Knowledge in CANopen protocol in industrial application (preferred CIA425).