Medical Manufacturing Operations Manager

The Manufacturing Operations Manager is a key operational leader for the Charlotte site and an active member of the Site Leadership Team (SLT), partnering closely with the General Manager, R&D, Quality, and Finance to support operational execution, customer satisfaction, and scalable business growth.

This role is responsible for leading day-to-day manufacturing operations across Production, Maintenance, Shipping & Receiving, and Manufacturing Support functions. The Manufacturing Operations Manager drives safety, quality, delivery, productivity, and continuous improvement while ensuring the site operates efficiently in a regulated medical device manufacturing environment.

The position provides direct leadership to Production Supervisors and operational support teams while helping develop operational strategies that improve performance, strengthen accountability, and support future growth.

Duties & Responsibilities

Operational Leadership

• Lead daily manufacturing operations to achieve safety, quality, delivery, and productivity goals.
• Provide leadership and direction for Production Supervisors, Maintenance, Shipping & Receiving, and related operational support functions.
• Partner with the Site Leadership Team to support business objectives, operational priorities, and customer commitments.
• Promote a culture of accountability, teamwork, urgency, and continuous improvement.
• Monitor operational performance and establish clear expectations through KPIs and performance metrics.

Manufacturing & Production Management

• Ensure efficient production scheduling and execution to meet customer demand and delivery expectations.
• Support manufacturing readiness for new product launches, process transfers, and production scale-up activities.
• Collaborate closely with R&D, Engineering, and Quality to transition products smoothly into manufacturing.
• Drive improvements in labor utilization, workflow, material flow, and operational efficiency.
• Oversee equipment uptime, facility coordination, and maintenance priorities to minimize operational disruptions.
• Support inventory accuracy and material flow through collaboration with warehouse and logistics teams.

Quality & Compliance

• Maintain compliance with ISO 13485, FDA regulations, and internal quality system requirements.
• Reinforce a culture of quality and operational discipline throughout manufacturing operations.
• Partner with Quality leadership on audits, CAPAs, nonconformances, and corrective actions.
• Ensure adherence to safety policies, procedures, and regulatory requirements.

Continuous Improvement

• Drive Lean Manufacturing and continuous improvement initiatives focused on safety, quality, delivery, and cost.
• Lead problem-solving and root cause investigations related to operational performance issues.
• Identify opportunities to improve processes, reduce waste, and increase operational effectiveness.
• Support implementation of standard work, visual management, and operational best practices.

Leadership & Team Development

• Coach and develop supervisors and operational teams to strengthen leadership capability and accountability.
• Foster employee engagement and strong communication across departments.
• Support performance management, employee development, and succession planning initiatives.
• Build strong cross-functional relationships across Operations, Quality, R&D, Supply Chain, and Finance.

Qualifications

• Proven operational leadership experience within a regulated manufacturing environment.
• Strong understanding of manufacturing operations, production flow, and operational execution.
• Ability to lead teams in a fast-paced environment while balancing quality, delivery, and efficiency.
• Experience collaborating cross-functionally with Engineering, Quality, Supply Chain, and Finance teams.
• Strong communication, organizational, and problem-solving skills.
• Ability to drive accountability and continuous improvement initiatives.

Education

• Bachelor's degree in Engineering, Operations Management, Business, or related field preferred.
• Equivalent manufacturing leadership experience will also be considered.

Experience

• Minimum 5–8 years of manufacturing leadership experience.
• Medical device or regulated manufacturing experience preferred.
• Experience leading production and operational support teams.
• Experience with ERP/MRP systems preferred.

Skills, Knowledge & Abilities

• Working knowledge of Lean Manufacturing and continuous improvement methodologies.
• Understanding of production planning, inventory control, and manufacturing processes.
• Strong leadership and employee development skills.
• Effective decision-making and problem-solving capabilities.
• Ability to manage multiple priorities in a dynamic manufacturing environment.
• Proficiency in Microsoft Office and ERP systems.

Physical Demands

• Work performed in both office and manufacturing environments.
• Requires standing, walking, and occasional lifting up to 25 lbs.
• Regular interaction with production floor and warehouse operations.

Acknowledgement