Systems Engineer (m/w/d) in der Medizintechnik
Core
Define product requirements from customer needs to technical specs for hardware and software systems, perform system analysis and modeling using SysML, and manage risks in medical device development.
Role type
Senior Systems Engineer (Medical Devices)
Builds
Medical devices and mechatronic products
Domain
Medical technology / Mechatronics
Deliverable
production ML models | product features
Required skills
Requirements management, System analysis and modeling (SysML), Risk management, Usability evaluation, Project management, Knowledge of regulatory standards (ISO 13485, IEC 62304, ISO 14971, IEC 62366)
Preferred skills
Variant management
Technologies
SysML
Responsibilities
Formulate requirements at all levels from customer to technical, align requirements with stakeholders, conduct system analysis and model processes, work on methodological development of systems engineering, participate in usability development and evaluations, identify product risks and define mitigation measures