The Production Manager is responsible for leading and managing manufacturing operations to achieve established production, quality, safety, cost, delivery, and efficiency objectives. This position provides overall leadership for production activities and is accountable for operational performance, workforce planning, production capacity, process efficiency, and continuous improvement within a regulated medical device manufacturing environment.

The Production Manager works closely with Quality, Engineering, Maintenance, Supply, Warehouse, Planning, and other functional leaders to ensure effective execution of production plans and alignment with customer and business requirements.

This role is responsible for developing a high-performing production organization through effective leadership, employee development, performance management, resource planning, and accountability for operational results.

Essential Duties & Responsibilities
• Lead and manage daily manufacturing operations to ensure production schedules, customer requirements, quality standards, and delivery commitments are achieved.
• Establish clear operational expectations and hold production leadership and employees accountable for performance, quality, safety, attendance, productivity, and adherence to company policies.
• Develop and manage staffing plans, labor requirements, shift structures, overtime, and workforce allocation to support current and future production needs.
• Partner with Planning and Supply Chain to establish production priorities, manage capacity, and address constraints affecting customer delivery.
• Monitor and manage key operational performance indicators, including production output, labor efficiency, scrap, rework, downtime, throughput, productivity, on-time delivery, and overall equipment utilization.
• Identify operational gaps and develop and execute corrective and preventive actions to improve performance and eliminate recurring issues.
• Lead continuous improvement initiatives focused on productivity, cost reduction, waste elimination, process optimization, and manufacturing efficiency.
• Partner with Quality to ensure compliance with company quality systems, ISO 13485 requirements, applicable medical device regulations, and established procedures and work instructions.
• Ensure production processes and documentation are executed consistently and accurately and that the manufacturing operation remains audit-ready.
• Partner with Engineering and Maintenance to improve equipment reliability, address downtime, support preventive maintenance activities, and optimize manufacturing processes.
• Collaborate with Warehouse and Materials teams to ensure appropriate material availability and flow to support production requirements.
• Lead investigations, root cause analysis, and corrective action activities related to production, quality, safety, equipment, and process issues.
• Review production performance and provide regular reporting, analysis, and recommendations to senior leadership.
• Identify opportunities to improve manufacturing capacity, workflow, equipment utilization, staffing efficiency, and overall operational performance.
• Participate in capital planning and provide input regarding equipment, tooling, facility, technology, and other resources required to support business growth and operational needs.
• Manage departmental expenses and labor costs within established budgets and identify opportunities for cost improvement.
• Lead, coach, and develop production supervisors, leads, and other production personnel to build a strong leadership pipeline and high-performing organization.
• Establish performance expectations and ensure timely completion of employee evaluations, coaching, development plans, and performance management activities.
• Support recruiting, selection, onboarding, training, and development of production personnel and leadership team members.
• Promote a culture of safety, accountability, teamwork, quality, and continuous improvement throughout the manufacturing organization.
• Ensure compliance with company policies, safety requirements, environmental requirements, SOPs, work instructions, and applicable regulatory requirements.
• Maintain a clean, organized, safe, and efficient manufacturing environment.
• Serve as a key operational leader during customer visits, internal audits, regulatory inspections, and other business-critical activities.
• Participate in strategic operational planning and support implementation of company initiatives and business objectives.
• Perform other duties and responsibilities as assigned by leadership.

Qualifications

Education & Experience
• Bachelor's degree in Manufacturing, Operations Management, Engineering, Business, or a related field preferred.
• Minimum of 5-7 years of progressive manufacturing experience, with increasing levels of responsibility.
• Minimum of 3 years of manufacturing leadership or management experience.
• Demonstrated experience managing production teams, operational performance, and manufacturing KPIs.
• Experience in medical device manufacturing, FDA-regulated manufacturing, or another highly regulated manufacturing environment strongly preferred.
• Experience with ISO 13485 and quality management systems preferred.
• Experience with dip molding, assembly, packaging, polymer processing, injection molding, or other manufacturing processes is preferred.
• Demonstrated experience with Lean Manufacturing, continuous improvement, root cause analysis, and problem-solving methodologies.
• Experience with workforce planning, production scheduling, capacity planning, and labor management.
• Experience managing departmental budgets, labor costs, or operational expenses preferred.
• Demonstrated ability to lead cross-functional teams and influence stakeholders across multiple departments.

Physical Requirements (if applicable)
• Ability to sit, stand, walk, or move throughout facility as required
• Ability to lift up to 30 pounds occasionally.
• Ability to work in a manufacturing environment with exposure to machinery, noise, and production materials.
• Ability to wear required PPE and comply with safety requirements.

Work Environment

This position operates within a manufacturing environment supporting production. The role may require flexibility in schedule, overtime, and support for multiple shifts base on business needs.