Risk Manager Medical Devices

Overview

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Job Posting Location: Functional Area: Quality. Working Model: Hybrid. Requisition ID: 9714. B. Braun Miethke GmbH & Co. KG based in Potsdam, is a joint venture between Aesculap AG - a subsidiary of the medical technology and pharmaceuticals manufacturer B. Braun Melsungen AG - and Christoph Miethke - founder and CEO of Christoph Miethke GmbH & Co. KG in Potsdam. We work passionately on the development of innovative drug delivery products with the aim of fulfilling previously unmet or barely met requirements of users and patients.

We are looking for you as a Risk Manager Medical Devices to drive forward the development and approval of our highly innovative medical products.

Would you like to work with us and inspire us with your commitment and passion? Help us to improve the quality of life of patients.

Responsibilities

• Maintenance and further development of the risk management file as per ISO 14971 for medical devices
• Continuous risk assessment based on data from the product life cycle
• Coordination of the FMEA team for the design FMEA (dFMEA) and documenting the results
• Coordination of the FMEA team for the production process FMEA (pFMEA) and documenting the results
• Development of Safety Case documentation as required by US Standard AAMI TIR

Expertise

• Master/Bachelor in Engineering (electronic/mechanical)
• Three years of experience in actively working on risk management activities for medical devices in accordance with ISO14971 or in moderating and documentation of FMEAs
• Experience in regulated industries like medical devices
• Experience in the development of safety case documentation as per AAMI TIR would be a plus

Personal competences

• Desire to work in a creative and committed team
• Independent, systematic and structured way of working
• Attention to detail and excellent documentation skills
• Excellent communication skills
• Good knowledge of English and German (verbal and written)

Our offer

• We offer you the opportunity to get actively involved and play a key role in shaping our product
• You will work in a friendly and international team in a young company, supported by the strengths and expertise of two large companies

Benefits

• Prospective permanent position in the attractive state capital of Potsdam which is in close proximity to Berlin
• Flexible working time
• Opportunity to gain additional qualifications and advance your career through job related training events