80 Beats Medical GmbH * Lead the design, development, and optimization of breakthrough medical devices, ensuring high reliability, safety, and performance. * Ensure compliance with relevant medical device regulations, including FDA, ISO, and other industry standards. * Ensure the successful development and delivery of medical systems at scale, balancing technical requirements, resource constraints, and stakeholder expectations throughout the project lifecycle. * Minimum of 7 years of experience in systems engineering, with a strong background in medical device development. * Knowledge of medical device regulations and standards (e.g., IEC 62304, ISO 13485). * Experience with safety-critical systems and software development life cycle (SDLC) methodologies is a must.
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