System Engineer (m/w/d), EKF - diagnostic GmbH, Barleben
Core
System Engineer responsible for concept, implementation, and quality assurance of complex medical device systems, ensuring system alignment for new device generations.
Role type
System Engineer (Medical Devices)
Builds
In-vitro diagnostic blood analysis devices (POC Analyzers)
Domain
Medical Technology / In-Vitro Diagnostics
Required skills
Systems Engineering, regulated environment experience (Medical Devices), System Requirements Management, External Partner Management, Complex Technical Systems Understanding (Hardware/Software/Interfaces), Analytical Problem Solving
Preferred skills
None stated
Technologies
None stated
Responsibilities
Derive, define, and maintain system requirements based on stakeholder, market, and product needs; Translate system requirements into the development process and ensure implementation; Manage and ensure quality of external development services; Collaborate with internal interfaces (R&D, Quality, Regulatory Affairs, Product Management) and external partners; Identify and utilize technical synergies between parallel development projects; Build and evolve system test and test automation concepts; Contribute to the sustainable evolution of the EKF system landscape across product generations.