AbbVie Deutschland GmbH & Co. KG
Together, we break through - as Senior Systems Engineer - Aesthetic Filler & Combination Products (all genders) We are looking for a Senior Systems Engineer to join our Device and Combination Product Development team in R&D. You will contribute to the development of exciting new aesthetic devices and therapeutic combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development. In this role you're also responsible for integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of devices, drug delivery systems from syringes to autoinjectors to complex electromechanical pumps, with a focus on Aesthetic Filler devices. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs. Make your mark Drive the implementation of holistic Systems Engineering principles within the Design Controls process, with a focus on system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture. Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards throughout the product development lifecycle. Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs. Oversee and integrate third-party development activities and ensure alignment of Design Control and Quality by Design activities. Collaborate with cross-functional team members to identify process gaps, recommend and implement improvements, and help standardize methods and ways of working to enhance consistency, efficiency, operational effectiveness, and the development of sustainable business and organizational strategies. Collaborate with cross-functional teams to plan and coordinate testing activities, including sample and laboratory resource planning, and drive improvements to processes, methods, and ways of working. Serve as the dedicated systems engineer for projects, independently owning key deliverables and coordinating stakeholder input as needed to support successful execution.