Software risk management according to iso 14971 and iec 62304
Identification and documentation of software hazards and risks
Coordination of software hazard analyses
Fresenius Medical Care is a global leader in kidney care dedicated to improving the quality of life for patients with chronic kidney disease
Job Summary
Fresenius Medical Care is a global leader in kidney care dedicated to improving the quality of life for patients with chronic kidney disease.
The role involves ensuring systematic management of software-related risks during the development of dialysis devices to guarantee product safety and regulatory compliance.
The company offers individual career development opportunities, a culture that encourages innovative thinking, and the benefits of a successful global corporation with a collegial medium-sized company culture.
Matching Summary
Fresenius Medical Care is a global leader in kidney care dedicated to improving the quality of life for patients with chronic kidney disease.
Skills & Requirements
Must-have
Software risk management according to ISO 14971 and IEC 62304
Identification and documentation of software hazards and risks
Coordination of software hazard analyses
Collaboration with software development and quality assurance
Experience with software development tools and MS Office
German and English language proficiency
Willingness to travel internationally about 10%
Nice-to-have
Experience in global and intercultural teams
Strong organizational and analytical skills
Communication and team collaboration skills
Knowledge of formal design controls and quality management systems
Innovative and goal-oriented work culture
Key Requirements
Degree in computer science, medical technology, or engineering
Minimum 5 years experience in software development or risk management
Knowledge of IEC 62304, IEC 61508, ISO 26262 or DO-178C
Experience in medical technology or HealthTech industry
Experience with product development under formal design controls
Fluent German and English skills
Willingness to travel nationally and internationally