Production & Manufacturing Manager

Production & Manufacturing Manager – Medical Devices

SOZO Brain Center is seeking an experienced Production & Manufacturing Manager to lead the manufacturing operations, technology transfer, and production oversight of an innovative neuromodulation medical device production line.

The successful candidate will be responsible for managing the transition of intellectual property, manufacturing know-how, quality systems, suppliers, and production activities from the current manufacturer to SOZO and its selected external manufacturing factory/partners. This role serves as the primary operational bridge between SOZO Brain Center, the former device owner, contracted factory manufacturers, suppliers, regulatory consultants, engineering teams, and quality management personnel.

The Production & Manufacturing Manager will ensure that production is transferred efficiently, regulatory requirements are maintained, product quality is preserved, manufacturing knowledge is documented, and future production capacity can scale to support international growth.

Key Responsibilities

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

Qualifications

• MUST have a permit or a 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.
• Proven experience managing external manufacturing partners and suppliers.
• Experience leading technology transfer or manufacturing transfer projects.
• Strong understanding of ISO 13485, EU MDR, and quality management systems.
• Experience in electronics manufacturing and assembly preferred.
• Experience with Class IIa and/or Class IIb medical devices preferred.
• Experience within neuromodulation, neurotechnology, medical electronics, or wearable medical devices is highly desirable.
• Multilingual
  

Travel Requirements

• Frequent travel to manufacturing facilities, suppliers, and partner organizations across Europe during the transition and scale-up phases.
• Minimal International travel as required.