Role Overview

The Operations Lead is a key leadership role in ensuring production readiness for new product introductions (NPI). This includes coordinating production setup, aligning engineering support, and ensuring all infrastructure, processes, and teams are ready for seamless product ramp-up. You will be responsible for building operational readiness in a regulated environment while also driving daily performance and continuous improvement.

Key Responsibilities

• Lead and optimize daily production activities, ensuring safety, quality, and delivery performance across catheter and sensor manufacturing.
• Prepare production for new product introductions, including resource planning, line layout, equipment readiness, documentation, and operator training.
• Coordinate with R&D, QA/RA, and Engineering to ensure smooth technology transfer and production scale-up for new products.
• Lead the Engineering function to support process validation, equipment qualification, and technical change implementation.
• Manage Maintenance and Facilities, ensuring uptime of manufacturing equipment and readiness of the production environment.
• Drive lean manufacturing initiatives to improve efficiency, reduce waste, and enhance operational capability.
• Define and monitor KPIs across production and technical operations, using data to inform decisions and continuous improvement.
• Build, mentor, and manage a cross-functional team of production operators, technicians, and engineers.

Ideal Candidate Profile:

• Bachelor’s or Master’s degree in Engineering, Manufacturing, or a related technical field.
• 5 years of experience in the medical device industry
• 3 years of experience in a relatable managerial role
• Proven experience leading cross-functional production readiness efforts in a regulated environment.
• Hands-on experience with equipment and process qualification, line setup, and validation documentation.
• Fluent in English; Dutch language skills are a plus.