EBG MedAustron GmbH in Wiener Neustadt operates one of the most modern centers for particle therapy and research in Europe. Cancer patients are treated with an innovative form of radiation therapy using protons and carbon ions.
About This Opportunity
Become part of the Medical Device Safety team as a System Engineer (f/m/x). This full-time position involves:
* Participating in the systems engineering process for the medical frontend
* Supporting the elaboration of requirements for new medical devices
* Collaborating closely with experts, system architects, and test managers throughout the development process
* Crafting comprehensive requirements, test strategies, enhancing product reliability and performance
* Supporting regulatory tasks and developing solutions according to MDR (Medical Device Regulation) and associated standards
* Providing expert-level support for the medical front end (On-Call)
* Hands-on work with system components (installation and commissioning)
Requirements
To be successful in this role, you should have:
* A completed academic technical study (DI or Master's degree preferred) in Engineering, Physics, or a related field
* A comprehensive understanding of the principles and concepts associated with active medical device development within a ISO 13485 certified QMS
* Familiarity with requirement engineering tools (e.g., Polarion) and other software, including proficiency with Microsoft tools
* Experience with systems modeling using UML-2 / SysML
* Proficiency in contemporary requirements elicitation, analysis, specification, and verification, with demonstrated ability to apply these skills effectively
* Preferrable experience with risk management according to ISO 14971 and medical software lifecycle according to IEC 62304
* Outstanding communication skills, coupled with the capability to collaborate seamlessly within a team or operate independently as required
* Willigness to occasionally work on weekends
We Offer
We provide attractive salary packages based on current market salaries. Further information about EBG MedAustron GmbH, our benefits, and what matters to us can be found here.