ResponsibilitiesPlan, coordinate, and control manufacturing operations for injection molding and automated assembly lines.Monitor and optimize equipment performance to ensure consistent quality and minimal downtime.Ensure full compliance with ISO 13485, FDA, GMP, and other applicable regulations.Collaborate with Quality Assurance on documentation, traceability, and validation.Lead root cause investigations and corrective actions for compliance or quality issues.Drive efficiency through process improvements using Lean, 5S, and Six Sigma methodologies.Analyze data to identify trends and implement continuous improvement initiatives.Supervise and mentor production staff, including technicians and supervisors.Promote a culture focused on safety, accountability, and ongoing learning.Optimize the use of labor, materials, and equipment to maximize production output.Coordinate with engineering and maintenance to ensure equipment reliability and rapid issue resolution.Enforce health, safety, and environmental standards, especially for automated and cleanroom environments.Lead risk assessments, safety meetings, and incident investigations.Prepare and deliver reports on production performance, compliance, and improvement plans to leadership.Maintain accurate records related to production, maintenance, downtime, and staff performance.QualificationsBachelor’s degree in an engineering discipline (or equivalent experience).10+ years of experience in injection molding and automation, including 4+ years in a leadership role.Expertise in injection molding, automated systems (e.g., robotics, PLCs, vision systems), and cleanroom environments.Strong knowledge of ISO 13485, FDA, GMP, and other medical device regulations.Proficient in Lean Manufacturing, Six Sigma, or similar methodologies.Skilled in leadership, problem-solving, and communication.Proficiency with ERP/MRP systems, manufacturing analytics tools, and Microsoft Office.
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