Senior Advanced Manufacturing Engineer
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About The Position
The Senior Advanced Manufacturing Engineer (AME) at Smith+Nephew plays a pivotal role in the operations of new production development. This position is designed for an individual who will act as the operations lead for select Biologics New Product Development (NPD) programs, ensuring that all projects align with the strategic goals of the company. The Senior AME will collaborate with multi-functional teams both locally and across various manufacturing sites to support the objectives of Smith+Nephew. A key responsibility of this role is to ensure that all timeline commitments are met while adhering to safety, quality, and cost requirements. In this capacity, the Senior AME will support the Global Operations Advanced Manufacturing Engineering team in launching new products into production specifically for the Smith and Nephew Biologics Franchise. The ideal candidate will demonstrate the ability to manage sophisticated programs from concept to commercialization with minimal guidance from management. This role requires a solid understanding of key medical standards, including FDA CFR Part 820 and ISO 13485, as well as familiarity with medical device requirements related to Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) for production equipment validation. The Senior AME will also be responsible for protocol development and will drive equipment, process, and software qualifications when necessary. Mentoring junior engineers is an essential aspect of this role, as is the ability to effectively listen and engage with team members to foster a collaborative work environment. The position requires a proactive approach to problem-solving, utilizing engineering principles to identify root causes and implement effective solutions.
