Shire Jobs

Summary:

The Systems Engineer III reports to the Manager of Systems Engineering and operates with the guidance of a Senior Systems Engineer, focusing on understanding and capturing customer needs; product functional and performance requirements; product architecture, constraints and trade-offs; design requirements; safety risk management; and technical risks for new product developed and sustaining legacy products. This role works in close collaboration with the project lead on assigned tasks with minimal supervision and provides inputs to product design, cost, and schedule. This role also engages in design reviews and helps resolve design challenges. They must exhibit an ability to grow in their understanding of product domain, organizational dynamics, and formal methods for Systems Engineering. They are expected to have a mastery of one or more tools used within the system engineering process and to assist others in their use. They shall specifically demonstrate an ability to maintain and streamline the requirements management infrastructure from a technical tools perspective as well as the associated processes. It is expected that they can deliver high quality work items according to their committed schedule.

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• Support cross-functional project teams in the design and development of medical imaging systems through phase gate product development process from concept to launch.
• Ensure that products and processes comply with applicable industry guidance, standards, and regulations.
• Work with clinicians, end users, and marketing to define and evaluate new innovative product concepts to address unmet customer and business needs.
• Support sustaining engineering initiatives for the strategic products manufactured in-house or at contract manufacturing sites.
• Support program management with strong project management skills to effectively manage the systems engineering-related deliverables.
• Communicate effectively with multidisciplinary teams to monitor project progress, manage critical path activities, and to ensure adherence to project milestones and timelines. Communicate project status through verbal and written reports as needed to Senior Management.
• Participate in post-market investigations as needed.

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