![]() Two years of experience in project leadership within a manufacturing, development or research environment.in Engineering (Mechanical or Electrical or related field) ![]() ![]() Demonstrated knowledge of the regulatory and compliance standards applicable to medical products.Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program.Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current.Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc).Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.Demonstrated experience driving CTQ flow-down to subsystems.BS Degree in Computer Science, Mechanical, Electrical or Biomedical Engineering.Reviewing and creating Design History File (DHF) deliverables per New Product Introduction (NPI) plans as required by the Quality Management System.Ensuring that the quality targets are satisfied and retires technical risks as they arise on the program.Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality.Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and testing.Working with cross-modality teams to sync up the design and implementation to ensure the design consistency and re-usability.Working with cross-functional teams to coordinate the system integration and ensure the balance between feature and functionality, quality, reliability, compliance and cost.Closely working with the program manager, product manager and lead program integrator to drive the program per program road map with given resources.Leading the design team in the development of verification and validation (V&V) planning and execution.Leading the design team and design control process from requirements development and design planning to design transfer.The role drives alignment of program scope to available resources and timing, the architecture, vision and design requirements in partnership with modality teams, third parties and imaging solution teams. Leads teams to deliver the technical content, performance, intellectual property and quality deliverables of a new product introduction (NPI) Program.
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