As Manufacturing Engineer working under an ISO13485:2016 Quality Management System, you will be expected to lead the effective and timely transfer of new medical device instrumentation (typically diagnostic test instruments) from development stages into serial production (New Product Introduction). In addition, you will support the testing and field service departments in case of technical challenges and others (Technical Support).

Among other items, core responsibilities include:

• Creation and maintenance of test documentation, service notes, validation and training documents for a range of medical device diagnostic instruments such as automated liquid handling robots, PCR/fluorescence instruments and related technologies
• Quality improvement of systems in the field of hardware, software and firmware
• Creation of OQPV routines and SOPs
• Creation and maintenance of DMR and DHR records for new and exisiting equipment
• Creation of repair and test documentation for external suppliers
• Training of internal employees and external partners

Qualifications:

• University degree or state-certified training as a technician specialising in the fields of electrical engineering, mechanical engineering, systems engineering or comparable
• Knowledge in the fields of analytical measurement technology, liquid handling, automation, or laser/detection technology
• Knowledge of PCR instrumentation for molecular diagnostics is an advantage
• Experience of working under an ISO13485:2016 or GMP environment is an advantage
• Good knowledge of MS Office
• Good English skills
• Independent, systematic and target-oriented working method
• Team spirit, commitment and flexibility
• Available for international business trips