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Manager R&D Systems Engineering Manager of Systems Engineering leads the organization in innovative systems approaches to both technical solutions and product development processes. Duties include assigning work and mentoring direct reporting System Engineers (Lead System Engineers / Lead System Designers) in their Systems Engineering tasks, including design and development, verification and validation testing, and investigations/root‑cause determinations. Responsible for the development of solutions to problems of high complexity and broad company implications. Essentials Duties - Manages and provides leadership and mentorship for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives. li>Subject Matter Expert to guide projects and mentor other System Engineers on one or more of the following areas: - Systems Engineering, Model Based Systems Engineering - Requirements Writing and Traceability - Integration Planning and Execution - Testing methodologies for verification and validation, product changes, and investigations - Risk Management, especially FMEAs for Design - Design Controls - Drives system engineering principles through robust engineering processes within team and cross‑functional counterparts. - Builds strong connections with functional counterparts to identify issues early and drive solutions with optimal consideration of the whole system. - Participates in the short‑ and long‑term planning process that establishes technical objectives for a business unit project or functional engineering group. - Utilizes technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to processes, projects, and products used globally. - Drives engineering excellence in product design transfer to manufacturing, procedure, and service. - Identifies project, product opportunities and initiates prioritization in addition to implementation. - Completes annual department budgeting and is accountable for long‑range planning. - Implements and understands FDA and global regulatory requirements as necessary. - Ensures compliance with company Quality System regulations and safe working practices. - Demonstrates broad management experience across and is recognized as an expert within and outside of the Company, with fully developed leadership skills and a deep understanding of vital issues across multiple unrelated functions. - Uses systems thinking to design complex platforms integrating equipment, software, and disposables, achieving functional and reliability goals. - Defines integration and verification plans, allocating adequate resources and time for execution. Other Duties and Responsibilities - May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. - Performs other tasks at manager’s request to ensure the success of projects and the overall business. Minimum Qualification Requirements Education - Bachelor’s degree or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered. - Bachelor of Science Degree in Engineering, strongly preferred. Experience - Minimum 8 years experience, 3 years managing others. - Minimum 5 years experience in one or of the following areas: - Systems Engineering, Model Based Systems Engineering - Requirements Writing and Traceability - Integration Planning and Execution - Testing methodologies for verification and validation, product changes, and investigations - Risk Management, especially FMEAs for Design - Design Controls - Successful execution in most if not all of the following areas: - Engineering product development such as requirements/specification development, risk management, verification and validation, or other systems engineering processes. - Experience in both systems engineering and software engineering. - Technical investigations and CAPA. - Regulatory inspections. - Manufacturing and supplier specification development. - Statistical tools – Statistical Process Control, Sampling, Design of Experiment. Skills - Change leader who identifies opportunities and then designs and implements solutions to capitalize on those opportunities. - Exceptional engineering skills and strong commitment to a rigorous process approach. - Demonstrated ability to lead a multi‑discipline engineering and scientific team both as a direct leader and via influencing. - Skilled ability to balance commercial and development needs to accomplish global business area goals. - Advanced understanding and application of Engineering Processes and Quality Management System applied to product development, transfer, and manufacturing. - Broad knowledge of engineering, management, quality, global regulatory standards, and/or manufacturing. - Ability to quickly gain working knowledge of the business’s products and therapeutic uses. - Effective leadership, managerial, and strategic planning skills. - Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application. - Knowledge and use of relevant PC software applications and skills to use them effectively. - Demonstrated ability to communicate effectively both verbally and in writing. #J-18808-Ljbffr