Beschreibung
Domain Skills: Class III Medical Device• Overall 15 + years of experience in Medical device SW development lifecycle
• Experience in Risk / Hazard analysis
• Knowledge in Premarket Approval (PMA) process for class III medical devices
• Understand customer requirements and conceptualize solutions that address key needs. Ability to create requirements into implementable software design.
• In-depth knowledge of current technological trends, developments and best practices in the area of information security, wireless network architecture, Cloud and mobile development
Technical Skills: C and C++
• 10 + years of experience in embedded software development using C and C++
• Knowledge of object-oriented analysis, object-oriented design, and object-oriented programming
• Should have experience is using multiple development tools like TFS, ReSharper, NUnit, NCover, Memory Profilers etc.
• Work with the development team in software design and reviews. In-depth knowledge of designing applications and design tools.
Process Skills: ISO 13485
• Working experience in ISO 13485 QA process and regulatory requirements (like FDA’s PMA, 510k, Cyber security etc.)
• Working experience in Class III Medical device Software development process
Qualification:
• A master’s degree in computer science, electrical engineering, industrial engineering or a comparable qualification
• German Language is Mandatory (Fluent)