Approval Engineer for Medical and Electrical Engineering | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik
FERCHAU GmbH Niederlassung Mannheim
Job Summary
This role involves ensuring the regulatory compliance and approval of electrical medical devices, operating at the intersection of medical technology and electrical engineering. The Approval Engineer will be responsible for executing CE conformity assessments, ensuring adherence to the Medical Device Regulation (MDR), and relevant standards like IEC/EN 60601-1. Key day-to-day tasks include organizing and conducting safety and EMC testing, creating and maintaining technical documentation compliant with MDR, and participating in risk management activities according to EN ISO 14971. The position requires strong professional experience, a degree in Electrical Engineering, Medical Technology, or Mechatronics, and fluent German alongside good English skills. This is an exciting opportunity for an experienced professional to take responsibility for complex development projects within the Pharma and Life Science sectors, contributing expertise to bring technologies to the next level.
Required Skills
Education
Completed university degree in Electrical Engineering, Medical Technology, Mechatronics, or comparable field
Experience
- Professional experience in the approval, certification, or development of electrical devices
- Long-standing professional know-how and expertise
Languages
Additional
- Not specified
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