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

Job Summary

This role seeks an experienced professional to drive the certification and compliance of electrical medical devices within the Pharma and Life Science sectors. Day-to-day responsibilities include performing CE conformity assessments, ensuring strict adherence to the Medical Device Regulation (MDR), and applying relevant technical standards such as IEC/EN 60601-1 and EN 61010-1. The engineer will organize and execute vital safety and EMC testing, manage technical documentation according to MDR requirements, and actively participate in risk management processes (EN ISO 14971). Furthermore, the role involves supporting the development department to ensure norm-compliant design and communicating effectively with external testing bodies and regulatory authorities. Ideal candidates possess a degree in Electrical Engineering, Medical Technology, or Mechatronics, coupled with long-standing expertise in device approval or development, excellent analytical skills, and fluency in German.