Director, Operations

About This Role

Directing supply chain, production, and production engineering is the core of this role, ensuring safety, quality, delivery, cost, and compliance. This position provides strategic and technical leadership for manufacturing scale-up, operational excellence, continuous improvement, and new product introduction within a regulated medical device environment.

Responsibilities

• Direct Supply Chain, Production, and Production Engineering activities in accordance with quality system procedures
• Lead daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements
• Develop and execute operational plans to improve quality, throughput, capacity, inventory, and cost performance
• Provide engineering leadership for manufacturing process development, equipment selection, automation, process validation, and continuous improvement
• Partner with Design Engineering, Quality, Regulatory, and Program Management to support new product introduction, design transfer, and manufacturing scale-up
• Oversee production planning, material availability, inventory management, supplier performance, and supply continuity
• Establish and monitor key performance indicators for safety, quality, delivery, productivity, inventory, and cost
• Develop departmental budgets, staffing plans, capital expenditure justifications, and resource recommendations
• Lead investigations and implementation of corrective and preventive actions related to manufacturing and supplier issues
• Ensure manufacturing processes remain validated and compliant with applicable medical device regulations, standards, and internal procedures
• Develop organizational capability through hiring, coaching, performance management, and succession planning
• Support internal, customer, and regulatory audits and ensure timely completion of Operations-related corrective actions
• Establish and maintain Standard Operating Procedures, work instructions, and forms related to areas of responsibility
• Work in accordance with quality system procedures
• Perform other duties as assigned by Supervisor

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or a related engineering discipline
• Minimum of ten (10) years of progressively responsible experience in medical device manufacturing or operations
• Minimum of five (5) years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams
• Demonstrated experience with manufacturing engineering, production operations, supply chain management, and quality systems
• Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer