Risk Manager (m/f/d)

Fresenius Group; Bad Homburg vor der Höhe; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a forward-thinking global healthcare group as a Risk Manager, where you'll oversee the entire product risk management for medical devices. This role offers the chance to work with cross-functional teams, ensuring compliance with ISO 14971 standards while contributing to making better medicine accessible worldwide. With opportunities for remote work and professional development, you'll thrive in a corporate culture that fosters innovative thinking and collaborative problem-solving. If you are passionate about risk management and have a background in engineering, this is the perfect opportunity to make a meaningful impact in the healthcare industry.

Leistungen

Remote Work Options

Career Growth Opportunities

Collaborative Work Environment

Diverse Team Culture

Qualifikationen

• Several years of risk management experience in regulated industries.
• Deep knowledge of ISO 14971 and risk management activities.

Aufgaben

• Responsible for planning and implementing risk management for medical devices.
• Collaborate with cross-functional teams to ensure compliance with risk management standards.

Kenntnisse

Risk Management

ISO 14971

FMEA Methods

Technical Reviews

Engineering Knowledge

Product Development

Medical Device Knowledge

English Fluency

German Language Skills

Ausbildung

Bachelor's Degree in Engineering

Master's Degree in Engineering

Technical Apprenticeship

Jobbeschreibung

Req#: 01b4fe94-aa98-5c43-ad0d-95f67f2df5d0

In your role as Risk Manager (m/f/d), you will be responsible for the entire product risk management of medical devices.

Your assignments

• Responsible for planning and implementing risk management, including creating and updating risk analyses for medical devices in compliance with relevant standards (e.g., ISO 14971).
• Specify countermeasures (requirement management).
• Collaborate with cross-functional teams including engineers, medical experts, human factors engineers, and project managers.
• Ensure all risk management activities align with the risk management plan.
• Oversee risk management transfer into production units.
• Plan and monitor risk assessments, integrating relevant findings into risk analyses.
• Reconcile risk analysis with pre-production defect management (anomaly reports).
• Assist in the creation of FMEAs and anomaly reports.
• Develop Risk Analyses and Risk Management Reports, maintaining up-to-date risk management files.

Your profile

• Bachelor's or master's degree in engineering or a related technical field, such as medical technology, or a technical apprenticeship with further training as a technician, along with relevant experience.
• Several years of risk management experience in regulated industries (medical devices, automotive, aerospace, etc.) or R&D.
• Passion for conducting in-depth technical reviews.
• Deep knowledge of ISO 14971 (risk management for medical devices).
• Good understanding of applying risk management activities.
• Experience with product or design development.
• Basic knowledge of FMEA methods and safety principles.
• Familiarity with medical device durables and disposables.
• Fluent in written and spoken English; German language skills are a plus.
• Willingness to travel domestically and internationally.

Our offer to you

Discover numerous opportunities at Fresenius, regardless of your field of expertise and experience:

• Option to work remotely, with individual planning in consultation with your manager.
• Contribute to making better medicine accessible worldwide, whether in front of or behind the scenes.
• Opportunities for self-directed career growth and professional development.
• A corporate culture fostering innovative thinking and collaborative problem-solving.
• A diverse team with wide-ranging skills, talents, and experiences.
• The benefits of a successful global company combined with the collegial atmosphere of a medium-sized enterprise.

About the company

Fresenius is a global healthcare group providing products and services for dialysis, hospitals, and home-based patient care. We also focus on hospital operations, engineering, and services for healthcare facilities.