Senior Manufacturing Engineer

Senior Manufacturing Engineer Medical DeviceLocation: NCExperience: 8 plus YearsAbout the Role:We are seeking a Senior Manufacturing Engineer with strong experience in the medical device industry to support and improve manufacturing operations. This role focuses on process development, new product introduction, and ensuring compliance with regulatory and quality standards while driving efficiency and continuous improvement.Key Responsibilities:Develop, optimize, and maintain manufacturing processes for medical device productionSupport new product introduction, process transfers, and scale up activitiesEnsure compliance with FDA regulations, ISO 13485, and GMP requirementsIdentify and resolve production issues using root cause analysis and corrective actionsDrive continuous improvement initiatives to enhance quality, yield, and efficiencyCollaborate with cross functional teams including Quality, R and D, and OperationsSupport validation activities and documentation as requiredKey Skills:Medical Device ManufacturingProcess Development and ImprovementFDA, ISO 13485, and GMP ComplianceRoot Cause Analysis and CAPALean Manufacturing and Continuous ImprovementRequired Qualifications:Bachelor’s degree in Engineering or related field8 plus years of experience in manufacturing engineering within medical devicesStrong understanding of regulatory requirements and production processesPreferred:Experience with process validation and NPILean or Six Sigma certification