Sr. Risk Management Engineer

Responsibilities

• Plan and execute system risk management processes for assigned medical and medicinal devices.
• Prepare and maintain risk analysis in compliance with relevant standards and guidelines.
• Specify risk reduction measures in cooperation with the Value Stream and requirement management.
• Ensure all risk management activities are executed according to the established risk management planning.

Requirements

• Engineering degree or equivalent professional experience.
• 2-4 years of experience in Quality Engineering, preferably within medical device manufacturing.
• 1-3 years of experience in R&D, Regulatory Affairs, or risk management.
• Deep expertise in FMEA methodology and statistical methods.
• Strong knowledge of medical device regulations including EU MDR 2017/745, FDA 21 CFR, and MDSAP.
• Proficiency with standards such as ISO 14971 and ISO 13485.
• Bilingual fluency in English and Spanish with excellent communication skills.
• Valid U.S. visa and availability to travel to the U.S. and other countries as required.
• Experience with tools such as TrackWise, QTRAK, or PDM systems like PTC Windchill.

Benefits

• Individual opportunities for self-determined career planning and professional development.
• A corporate culture that encourages innovative thinking and collaborative problem-solving.
• The opportunity to work with a team of committed professionals in a diverse environment.
• The stability of a successful global corporation combined with a collegial, mid-sized company culture.

About the Company

Fresenius Medical Care is the global leader in kidney care, dedicated to improving the lives of patients with chronic kidney disease. We provide high-quality, innovative products and services across the entire healthcare journey, supported by a global team of over 110,000 employees. Our mission is to create a future worth living for patients worldwide, every day.