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R&D Systems Verification Lead - Electrophysiology

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Job Description - R&D Systems Verification Lead - Electrophysiology

Lead a team of system engineers including recruiting, hiring, mentoring, professional development, and performance coaching. Develop the system engineering discipline through focus on system verification capabilities and a system of systems mindset. Own and refine the overall process and planning for integration and system verification. Support planning and execution of systems level testing, including manual and automated systems test development. Responsible for organizational fluency in key standards for capital equipment and SUD such as ISO 60601. Develop, maintain, and communicate the scheduling and resourcing needs for all systems verification activities Oversee and drive the system of system development lifecycle, with an emphasis on testing, deployment, and maintenance. Support a high-performing team culture and entrepreneurial environment where people are highly engaged, skilled, and collaborative. Help build engagement within the site and team. Effectively communicate with different levels of management, as well as business and technical employees. Demonstrate effective change leadership. Demonstrate ability to succeed in fast paced environment while managing multiple projects simultaneously. Deep dive technically where needed while keeping a broad perspective. Build strong collaboration with development sites and cross-functional partners. Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in medical device systems engineering, human factors, design controls, and testing. Successful history of launching and maintaining products within the medical device industry Demonstrated expertise in systems engineering for the design, development and testing of medical devices. Demonstrate a keen interest in workflows, clinical features, and user experience. Ability to lead a cross functional site and build engagement. Ability to lead a multi-site team and collaborate with peers in different locations. Experience working with requirement management, collaboration, and issue tracking tools such as Jama and Jira. Working knowledge of hardware, firmware, and software evaluation to standards such as IEC 62304 and ISO 60601 Lead a group or team of employees in the development and achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Ability to direct and control the activities, budget, and headcount for the systems engineering organization. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Bachelor of Science degree in a relevant engineering discipline with 10+ years of experience developing highly complex systems 8+ years' experience managing technical teams in the development of medical device system of systems.
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