QUALIFICATIONS AND JOB DESCRIPTION
We are looking for a "Risk Management Engineer" for one of our global & multinational customer who operates in the medical sector.
QUALIFICATION
? Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering, Biomedical Engineering
? Excellent command of both written & spoken English; German is an asset
? Experience in product risk management in medical technology is an asset
? Experience with the relevant standards (DIN EN ISO 14971, 13485; IEC 60601-1) in the field of medical technology is desirable
? Knowledge/experience of/with ISO 13485
? Experience in using a risk analysis tool is desirable
? Good knowledge of MS Office applications
? Able to work with multinational teams
JOB DESCRIPTION
? Ensuring the risk management process in accordance with applicable standards and
regulations
? Creates, reviews and maintains risk management file (RMF) according to established
procedures and relevant regulations (MDR / 21CFR820)
? Implementation of ISO 14971 in the internal risk management process for the medical device
during the entire life cycle of the product
? Actively participates in R&D study activities, contributing to the identification and
assessment of the key risks
? Preparation of benefit / risk assessments in collaboration with the medical experts
? Maintenance of the risk management tool used
? Support of the clinical evaluation studies
