Details: The Senior Systems Engineer in the Systems Engineering team shall develop and support in-vitro diagnostics (IVD) systems comprising of software, instrumentation hardware, and disposables; participating as the development lead in cross-functional project teams. He/she shall work as a subject matter expert, to plan the development activities, solving in-depth and cross-functional problems or scientific/technical challenges; by utilizing expertise in systems integration of software, hardware, and disposables components. He/she shall have a working knowledge of network connectivity and cybersecurity requirements for IVD platforms. • Lead development of IVD systems, from requirements through design and implementation, through validation and to customers. • Define the architecting of systems solutions. • Contribute to the drafting and review of development agreements with outside partners and vendors. • Oversee outside partners and vendors work and progress towards developing IVD system products, including prototype testing, defect reviews, design reviews, V&V • Work with Global Marketing in the development of customer requirements, and develops product requirements using requirement management methodologies, including change management. • Work with internal stakeholders to facilitate the collection of business and regulatory requirements. Ensure alignment of customer and business needs. • Develop system level product requirements and component requirement documents. • Define and prepare a schedule of development tasks. • Mentor others on systems engineering best practices and procedures. • Conduct patient safety risk management activities according to FDA and ISO regulations. • Establish product configuration management. • Plan and perform integration testing. Establish software ad-hoc testing strategy. • Support verification and validation activities. • Present and document work product to meet needs of project and business.
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