Medical Device Industry jobs

Operations Manager – Medical Device Manufacturing

Key Responsibilities

• Oversee and manage daily manufacturing operations, including production planning, supply chain, procurement, logistics, and facility maintenance.
• Ensure full compliance with ISO 13485, FDA, and international medical device regulations.
• Lead process improvement and lean manufacturing initiatives to increase efficiency, quality, and cost-effectiveness.
• Collaborate with cross-functional departments such as engineering, quality assurance, and regulatory affairs to meet production and compliance goals.
• Manage internal and external audits and ensure accurate and current documentation of operational processes.
• Develop and track OKRs to measure operational effectiveness and identify areas for improvement.
• Lead, coach, and develop operational teams to achieve high performance and foster a culture of accountability and innovation.
• Manage operational budgets and implement cost-saving strategies while maintaining quality and compliance standards.
• Maintain a safe and compliant work environment in accordance with health and environmental regulations.

Requirements

• Bachelor’s degree in Engineering, Operations Management, Manufacturing, or a related field. A Master’s degree is a plus.
• Minimum 5 years of experience in operations management within the medical device manufacturing industry.
• ISO 13485 certification and strong knowledge of medical device quality management systems.
• Experience with FDA, CE Marking, and MDR regulatory frameworks.
• Proven track record of leadership in a manufacturing environment, with hands-on experience in process optimization.
• Strong analytical, organizational, and decision-making skills.
• Proficient with ERP systems and operational reporting tools.