Approvals Engineer (m/f/d) Medical Technology and Electrical Engineering | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik
FERCHAU GmbH Niederlassung Mannheim
Job Summary
Join FERCHAU as an ambitious Approvals Engineer specializing in Medical Technology and Electrical Engineering. In this full-time role, you will be instrumental in ensuring electrical medical devices meet stringent regulatory requirements, including CE conformity assessments and adherence to the Medical Device Regulation (MDR) and relevant standards like IEC/EN 60601-1. Your responsibilities will include organizing safety and EMC testing, maintaining technical documentation, participating in risk management according to EN ISO 14971, and supporting the development team with compliant design. You will also act as a liaison with external testing bodies and authorities. This position offers opportunities for professional growth and is ideal for experienced individuals looking to advance technology in the Pharma and Life Science sectors.
Required Skills
Education
Completed degree in Electrical Engineering, Medical Technology, or Mechatronics, or a comparable qualification.
Experience
- Experience in the approval, certification, or development of electrical devices
- Professional experience in Medical Technology and Electrical Engineering
- Experience with relevant standards: IEC/EN 60601-1, EN 60335-1, EN 61010-1, EMC Directives
- Experience in risk management according to EN ISO 14971
- Experience in conducting CE conformity assessments for electrical medical devices
Languages
Additional
- Not specified
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