Director of Operations

Director of Operations

Onsite in Charlotte, NC

Full-Time

The Director of Operations is a strategic operational leader and key member of the Charlotte site Senior Leadership Team (SLT), collaborating with the GM, Controller, Quality Manager, Commercial Sales Manager, and Production Managers.

This role provides comprehensive leadership across Production, Manufacturing Engineering, and Material Logistics, ensuring efficient manufacturing operations to support the commercialization and scale-up of complex medical devices.

The Director is responsible for driving operational excellence, leading manufacturing engineering execution, and ensuring successful production transfer and ramp-up into manufacturing. The role partners with the GM and SLT on site-level financial performance, including shared P&L accountability, cost optimization, and margin improvement.

Responsibilities

Senior Leadership & Organizational Leadership

• Serve as a key member of the site Senior Leadership Team, contributing to strategic planning, operational direction, and business performance.
• Lead Production, Manufacturing Engineering, and Material Logistics functions.
• Develop and optimize organizational structure to support scalability, efficiency, and growth.
• Establish clear performance expectations and accountability through KPIs.
• Drive a culture of engagement, accountability, and continuous improvement.
• Promote and reinforce company core values across the organization.

Manufacturing & Operational Management

• Direct daily manufacturing operations to meet quality, delivery, and cost targets.
• Ensure compliance with Quality Management System (ISO 13485), regulatory requirements, and safety standards.
• Manage labor, overhead, equipment, and facilities to meet production goals and support 15–20% annual growth without linear increases in headcount.
• Oversee manufacturing engineering activities, including process development, process validation, tooling, fixturing, and continuous improvement.
• Drive optimization of manufacturing processes to improve efficiency, yield, and cost.
• Manage capital equipment utilization and recommend investments aligned with operational needs.

Production Transfer & Manufacturing Readiness

• Own execution of production transfers into manufacturing, ensuring readiness for launch, scale, and sustained production.
• Lead Manufacturing Engineering's role in transfer activities, ensuring processes are robust, validated, and production-ready.
• Partner cross-functionally (Engineering, Quality, Program Management) to ensure seamless transition from development into production.
• Identify and mitigate risks during transfer and ramp-up phases.
• Establish and standardize best practices for transfer execution and manufacturing readiness.

Financial & Strategic Accountability

• Partner with the GM and SLT on site-level P&L, influencing cost structure, margin performance, and operational efficiency.
• Own COGS and drive year-over-year margin improvement through Lean Manufacturing and Six Sigma methodologies.
• Manage departmental budgets, including labor, overhead, and capital expenditures.
• Align operational strategy with overall site business objectives.

Capacity Planning & Operational Scaling

• Lead capacity planning across labor, equipment, and facility footprint.
• Drive automation and process efficiency initiatives to support scalable growth.
• Design and implement production lines capable of meeting customer demand and forecast variability.

Quality, Compliance & Risk Management

• Foster a culture of quality and compliance across all operations.
• Ensure adherence to regulatory requirements and internal quality systems.
• Partner with Quality leadership on audits, CAPAs, and risk mitigation.
• Identify and proactively mitigate operational and supply chain risks.

Supply Chain & Customer Collaboration

• Collaborate with Material Logistics to optimize inventory, reduce risk, and ensure supply continuity.
• Partner with Commercial Sales and SLT to align production with customer demand.
• Manage customer expectations related to delivery, lead times, and operational constraints.

Continuous Improvement & Performance Management

• Establish and monitor KPIs across Quality, Safety, Delivery, Productivity, Scrap, and Transfer Success.
• Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
• Lead root cause analysis and implement sustainable corrective actions.
• Develop leaders and teams through coaching, performance management, and succession planning.

Qualifications

• Proven leader capable of driving results in a fast-paced, regulated manufacturing environment.
• Demonstrated success leading manufacturing operations and manufacturing engineering teams.
• Strong understanding of P&L drivers, COGS, labor, and operational financial metrics.
• Experience leading or supporting production transfers and manufacturing ramp-up.
• Ability to lead cross-functional teams and influence at the senior leadership level.

Education

• Bachelor's degree in Engineering, Life Sciences, or related technical field required.
• Master's degree (MBA or technical discipline) preferred.

Experience

• Minimum 10 years of leadership experience in manufacturing.
• Minimum 10 years in medical device manufacturing preferred.
• Experience leading Manufacturing Engineering and Production functions.
• Proven track record of successful production transfers and scaling operations.
• Experience contributing to site-level P&L and margin improvement.

Skills, Knowledge, and Abilities

• Strong expertise in manufacturing engineering principles, including process validation, tooling, and process optimization.
• Deep knowledge of Lean Manufacturing and Six Sigma methodologies.
• Experience with ERP/MRP systems (IQMS, Epicor, or similar).
• Strong financial acumen and ability to link operations to business performance.
• Excellent leadership, communication, and interpersonal skills.
• Strong analytical thinking and problem-solving capabilities.
• Ability to influence across functions and lead in a matrix environment.

Physical Demands

• Work performed across office, manufacturing floor (including controlled environments), and warehouse.
• Requires standing, walking, and occasional lifting up to 25 lbs.