Approval Engineer for Medical and Electrical Technology | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik
FERCHAU GmbH Niederlassung Mannheim
Job Summary
This role involves acting as an Approval Engineer, specializing in ensuring electrical medical devices comply with European regulations. Key responsibilities include conducting CE conformity assessments and ensuring adherence to the Medical Device Regulation (MDR) and relevant standards like IEC/EN 60601-1 and EN 61010-1. The professional will manage and execute safety and EMC testing, maintain technical documentation according to MDR requirements, and participate in risk management processes (EN ISO 14971). The position requires a degree in Electrical Engineering, Medical Technology, or Mechatronics, coupled with professional experience in the approval, certification, or development of electrical devices. Success in this role demands strong analytical skills, a structured approach, and fluency in German, alongside good English proficiency, making it ideal for experienced engineers looking to drive complex development projects in the Pharma and Life Science sectors.
Required Skills
Education
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 expertise and know-how
Languages
Additional
- Not specified
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