Project EngineerOur client specializes in medical device manufacturing. They are looking to hire a Project Engineer, as a direct hire.What you will be doing:Spearhead end-to-end product development for groundbreaking medical device programs, guiding projects from initial concept through successful production launchDesign products and tooling hands-on using SolidWorks CAD, 3D printing technologies, manual machining, and precision hand toolsBridge communication between internal teams and customers as the primary liaison, ensuring perfect alignment on strategy, deliverables, and critical timelinesOrchestrate cross-functional excellence by coordinating seamless activities between R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply ChainLaunch new production lines with expert oversight of procedure development, line clearance protocols, and comprehensive operator trainingChampion quality and compliance by providing hands-on support for manufacturing processes and quality systems (FDA QSR, ISO 13485)Drive validation success through IQ/OQ/PQ/PPQ activities, Test Method Validations, and rigorous Process CharacterizationLead continuous improvement initiatives to enhance project execution, documentation quality, and system efficienciesDeliver compelling communications on project status, milestones, risks, and mitigation strategies to all stakeholders including executive leadershipMentor rising talent by developing junior engineers and strengthening team capabilities in project management and engineering best practicesOptimize supplier relationships to resolve challenges, identify opportunities, and elevate performance standardsUncover cost-saving opportunities through innovative process improvements, automation solutions, and lean manufacturing principlesWhat you bring:Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related engineering discipline7+ years of proven experience in regulated medical device manufacturing or product developmentAdvanced proficiency in SolidWorks and cutting-edge design technology solutionsExceptional documentation, organizational, and communication abilitiesIn-depth knowledge of FDA regulations, ISO 13485, and GMP requirements