Senior Manufacturing Engineer

Senior Manufacturing EngineerWe are seeking a Senior Manufacturing Engineer to lead manufacturing readiness, process improvement, and validation work for durable and disposable medical devices. This is an opportunity to make a meaningful impact on products that support patient care while helping shape efficient, scalable manufacturing operations. In this role, you will support product commercialization, improve production performance, and ensure manufacturing processes meet quality and regulatory requirements. You will join a team that values collaboration, steady execution, and continuous improvement, and the role is well suited for someone who takes ownership of technical decisions, works comfortably with complex data, and brings structure to fast-moving engineering challenges.Core ResponsibilitiesLead manufacturing engineering support for product launches, process changes, and sustained production across multiple manufacturing operationsCoordinate equipment installation, validation, and process verification activities to support safe, effective, and scalable productionAnalyze manufacturing and test data to identify root causes, improve process performance, and recommend practical solutionsWrite and execute validation protocols, technical reports, and change documentation in compliance with regulatory and quality standardsDrive lean manufacturing and continuous improvement initiatives to reduce waste, improve throughput, and strengthen product qualityLead and support new product introduction activities from development through production ramp, including process development, tooling, work instructions, and capacity planningPartner with cross-functional teams to improve manufacturability, support capital equipment planning, and implement new production technologiesConduct design-for-manufacturability reviews and provide actionable feedback to simplify production, reduce cost, and improve consistencySupport process risk analysis, pilot builds, and launch readiness activities to help ensure smooth product transfers into manufacturingTrack project milestones, communicate progress clearly, and support execution against timelines and operational prioritiesRequired Skills & AbilitiesStrong technical judgment and the ability to make sound decisions in complex manufacturing environmentsComfort working independently on analytical, detail-intensive engineering problemsAbility to troubleshoot production issues using data, testing, and structured problem-solving methodsStrong documentation skills, including validation protocols, reports, and change control recordsWorking knowledge of regulated manufacturing environments such as FDA, ISO, or similar quality systemsExperience supporting new product introduction, design transfer, or manufacturing scale-up activitiesExperience using engineering and project tools such as CAD software, Excel or statistical analysis tools, and project management platformsAbility to collaborate effectively across engineering, quality, operations, regulatory, and leadership teams while maintaining ownership of assigned workOther RequirementsBachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical field5+ years of experience in manufacturing engineering, preferably in medical devices or another regulated manufacturing environmentFamiliarity with equipment validation protocols such as IQ/OQ/PQAbility to work on-site in Columbia, SC at least 4 days per weekAbility to use standard office, laboratory, and measuring equipmentMay be required to lift items up to 50 pounds