Senior Research and Development Engineer, Systems

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    "description": "<h2>Overview</h2>\n<p>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.</p>\n<h2>Responsibilities</h2>\n<ul>\n <li>Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, anduser stories.</li>\n <li>Conduct risk management activities including risk analysis for system, software, and cybersecurity.</li>\n <li>Lead systems integration efforts across various engineering disciplines.</li>\n <li>Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.</li>\n <li>Ability to effectively work and communicate in technical cross-functional teams to develop new products.</li>\n <li>Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes.</li>\n</ul>\n<h2>Qualifications</h2>\n<p><strong>Required Qualifications:</strong></p>\n<ul>\n <li>BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred</li>\n <li>Minimum of 5 years of experience analyzing system requirements, design, and testing</li>\n <li>Software integration, and black box testing methodologies</li>\n <li>Experience with multi-tasking real-time operating system</li>\n <li>Agile development experience</li>\n <li>Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971</li>\n <li>Experience and understanding of Design Controls and SDLC</li>\n</ul>\n<p><strong>Preferred Qualifications:</strong></p>\n<ul>\n <li>Familiarity with best practices of software development for medical devices</li>\n <li>Strong Project Management skills</li>\n <li>Familiarity with Agile, GitHub, and Azure Dev Ops</li>\n</ul>\n<p> </p>\n<p><strong>Physical Requirements:</strong></p>\n<ul>\n <li>Works under general office environmental conditions</li>\n <li>Sitting for extended periods, utilizes close visual acuity for working with computers, etc.</li>\n <li>Ability to travel 25% of the time</li>\n</ul>",
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