The Project Manager is responsible for planning, executing, and closing projects related to the manufacturing of medical devices. This role ensures projects are delivered on time, within scope, and in compliance with regulatory standards such as ISO 13485 and FDA requirements. The Project Manager collaborates closely with cross‑functional teams—including Engineering, Quality, Operations, Supply Chain, and Regulatory Affairs—to support new product introductions, process improvements, and plant-wide initiatives. Responsibilities Lead, coordinate, and manage projects from initiation through completion, ensuring alignment with business objectives and manufacturing requirements. Develop and maintain project plans, timelines, budgets, and resource allocations. Facilitate communication and collaboration among cross‑functional teams. Identify project risks, develop mitigation plans, and ensure proactive problem‑solving. Oversee execution of engineering validations, process qualifications, and documentation updates in compliance with medical device standards. Ensure all project activities meet regulatory and quality requirements (ISO 13485, FDA 21 CFR Part 820, GMP). Drive continuous improvement projects using Lean, Six Sigma, or similar methodologies. Track project progress and report status, key metrics, and deliverables to management. Support new product introductions (NPI), equipment installations, and process transfer activities. Manage change control activities related to project scope, timelines, and costs. Qualifications Bachelor’s degree in Engineering, Industrial Engineering, Manufacturing, or related field. 5+ years of experience in project management within medical device manufacturing or highly regulated industries (aerospace). Strong understanding of ISO 13485, FDA regulations, GMP, and validation processes. Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies (preferred). Project Management Professional (PMP) certification (a plus). Excellent organizational, communication, and leadership skills. Ability to manage multiple projects simultaneously and work under tight deadlines. Proficiency in project management software (MS Project, Smartsheet, or similar). #J-18808-Ljbffr