Production & Manufacturing Manager – Medical Devices

About the role

The Production & Manufacturing Manager will lead the transfer and oversight of a neuromodulation medical device production line, acting as the operational bridge between SOZO Brain Center, contract manufacturers, suppliers, regulatory consultants, engineering, and quality teams.

Key responsibilities

• Lead the transfer of manufacturing operations, technical documentation, and production know‑how from the current manufacturer to SOZO and its external partners.
• Serve as primary liaison among SOZO, contract manufacturers, suppliers, regulatory consultants, and quality teams.
• Oversee production planning, schedules, inventory, and supply‑chain activities to ensure uninterrupted product availability.
• Monitor external manufacturing partners for compliance with quality, regulatory, and delivery requirements.
• Establish and maintain manufacturing procedures, work instructions, testing protocols, and production documentation.
• Ensure compliance with ISO 13485, EU MDR, and other applicable medical‑device regulations.
• Implement quality‑control processes, investigate non‑conformities, and drive CAPA.
• Coordinate supplier qualification, performance monitoring, and risk mitigation.
• Lead continuous‑improvement initiatives to boost efficiency, scalability, and cost‑effectiveness.
• Manage engineering changes and product updates within manufacturing operations.
• Identify and mitigate manufacturing, quality, and supply‑chain risks while maintaining business continuity.
• Prepare regular reports on production performance, quality metrics, costs, and operational risks for senior management.
• Support development of long‑term manufacturing strategy, including future expansion and scaling.

Required profile

• Valid permit or license to work in the EU.
• Bachelor’s degree in Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or a related discipline.
• Minimum 5 years of experience in medical‑device manufacturing or operations management.

Required skills

• ISO 13485 compliance
• EU MDR knowledge
• CAPA (Corrective and Preventive Action) implementation
• Supplier qualification and performance monitoring
• Manufacturing procedures and work‑instruction development
• Testing protocol design
• Production documentation management
• Quality‑control process implementation
• Engineering change management
• Risk mitigation in manufacturing and supply‑chain contexts