Manufacturing Engineer

Job Summary:Manufacturing Engineer with 3–4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. Experienced in manufacturing operations, process validation (IQ/OQ/PQ), configuration management, and continuous process improvement. Skilled in managing product data and documentation through PTC Windchill and MES systems while ensuring compliance with quality and regulatory standards.Strong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control.Roles & Responsibilities:Supported manufacturing engineering activities in a regulated medical device manufacturing environmentManaged part creation, BOM development, updates, and configuration control using PTC WindchillMaintained and updated MES documentation and manufacturing procedures to ensure compliance and traceabilityParticipated in process development and process characterization activities to improve manufacturing efficiencyExecuted and supported IQ/OQ/PQ validation activities for manufacturing processes and equipmentDeveloped and maintained PFMEA (Process Failure Mode and Effects Analysis) to identify and mitigate process risksPerformed statistical analysis using Minitab to support process improvement and data-driven decision-makingCollaborated with cross-functional teams including manufacturing, quality, and R&D to ensure smooth production workflowsSupported continuous improvement initiatives to enhance product quality, yield, and operational efficiencyEnsured adherence to regulatory requirements and internal quality management systemsExperience:3–4 years of experience in medical device manufacturing or highly regulated manufacturing environmentsHands-on experience with PTC Windchill for PLM and configuration managementExperience working with MES (Manufacturing Execution Systems) and manufacturing documentation controlExposure to process validation activities including IQ/OQ/PQExperience in PFMEA development and maintenance for risk analysisWorking knowledge of statistical tools such as Minitab for process analysis and improvementStrong communication, teamwork, and cross-functional collaboration skills in regulated environmentsEducation:Bachelor's degree in Mechanical, Industrial, Biomedical Engineering, or related field