Approval Engineer for Medical and Electrical Engineering | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik

Job Summary

This role involves acting as an Approval Engineer, focusing on the conformity assessment and regulatory approval of electrical medical devices. Day-to-day responsibilities include conducting CE conformity assessments, ensuring strict adherence to the Medical Device Regulation (MDR) and relevant standards such as IEC/EN 60601-1 and EN 61010-1. The engineer will organize and execute safety and EMC tests, manage technical documentation according to MDR requirements, and participate actively in risk management processes following EN ISO 14971. This position requires strong collaboration with the development department to ensure design compliance and involves communication with external testing bodies and regulatory authorities. The ideal candidate holds a degree in Electrical Engineering, Medical Technology, or Mechatronics, possesses professional experience in the certification or development of electrical devices, and is proficient in both German and English, making this an excellent opportunity for experienced professionals looking to drive complex development projects in the Pharma and Life Science sectors.