Senior Research and Development Engineer, Systems
Cook Medical · Bloomington, Indiana, US
Overview This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integ...
Job description
Overview This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables. Responsibilities: - Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, anduser stories. - Conduct risk management activities including risk analysis for system, software, and cybersecurity. - Lead systems integration efforts across various engineering disciplines. - Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971. - Ability to effectively work and communicate in technical cross-functional teams to develop new products. - Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes. Qualifications: Required Qualifications: - BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred - Minimum of 5 years of experience analyzing system requirements, design,...