Head of Manufacturing & Supply Chain Operations

Direct supply chain, production, and manufacturing engineering activities in accordance with established 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 introductions, design transfers, and manufacturing scale-up.

Oversee production planning, material availability, inventory management, supplier performance, and supply continuity.

Establish and monitor key performance indicators related to safety, quality, delivery, productivity, inventory, and cost.

Lead investigations and the 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 capabilities through hiring, coaching, performance management, and succession planning.

Support internal, customer, and regulatory audits and ensure the timely completion of Operations-related corrective actions.

Bachelor’s degree in Mechanical, Manufacturing, or Electrical Engineering, or a related engineering discipline.

At least 10 years of progressively responsible experience in medical device manufacturing or operations.

At least five years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams.

Demonstrated experience in manufacturing engineering, production operations, supply chain management, and quality systems.

Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer.

Experience managing budgets, capital projects, resource plans, and operational performance metrics.

Experience leading operations within a Class II or Class III medical device environment.

Working knowledge of FDA Quality System Regulation, ISO 13485, and applicable international medical device requirements.

Experience working with enterprise resource planning and manufacturing execution systems.

Experience implementing automation, Lean Manufacturing, Six Sigma, and structured continuous improvement methodologies.

Strong analytical and problem-solving skills with the ability to make data-driven decisions.

Excellent communication skills, including the ability to influence cross-functional teams and represent Operations to internal and external stakeholders.

Ability to manage multiple priorities in a fast-paced, highly regulated manufacturing environment.

#