Beschreibung
For one of our German Medtech clients in Baden-Wurttemberg we are seeking freelance support as:Technical Documentation for active medical devices (M/F/D)
Tasks:
• Carry out technical documentation, MDR documentation & design transfer
• Create system requirements, test requirements, specifications
• Define test cases & evaluation of risks
Qualification:
• Experience in validation of active medical devices
• Experience in handling ISO 13485, ISO 60601
• Basic knowledge of the requirements of the MDR
• Background: Engineer (electric/ mechanics/development)
•
• Experience in risk management
• Must have: Business fluent in English
• Nice to have: German
Requirements:
• Start: ideally mid of February/ beginning of march
• Duration: 6 months - with option of extension
• Capacity: Full time (2 days remote possible), 4 days (1 day remote possible)