Production Manager (Regulated Medical Device Manufacturing)We are looking for a skilled and dedicatedProduction Managerto lead our manufacturing operations and ensure the efficient, high-quality production of medical devices. This pivotal role demands expertise in regulatory compliance, process improvement, and strong team leadership.Key ResponsibilitiesOperational Oversight: Direct daily production activities to meet critical targets for safety, quality, delivery, and cost .Team Leadership: Manage, train, and develop production teams, including supervisors, leads, and operators, fostering a high-performance work environment.Materials and Logistics: Manage production planning and scheduling to align output with customer demand, including oversight of materials management and warehouse operations.Compliance and Quality: Ensure all manufacturing processes strictly comply with FDA, ISO 13485, and other relevant regulations.Planning & Control: Oversee production scheduling and resource allocation, managing inventory and output to align with customer demand.Continuous Improvement: Monitor key performance indicators (KPIs) and lead initiatives to optimize processes using Lean and Six Sigma methodologies.Cross-Functional Collaboration: Partner with Engineering, Quality Assurance, and Supply Chain to resolve production issues and support the transfer of new products into manufacturing.Documentation & Audits: Maintain accurate production documentation and lead manufacturing-related audits and inspections.Required QualificationsExperience: A minimum of 5 years of experience in a production management role within the medical device or a similarly regulated manufacturing environment.Education: Bachelor's degree in Engineering, Manufacturing, or a related technical field.Technical Expertise: Strong working knowledge of GMP, ISO 13485, and FDA regulations.Skills: Proven leadership ability, team development experience, and practical application of Lean Manufacturing and Six Sigma principles.Communication: Excellent problem-solving, organizational, and professional communication skills.