Production Manager

Responsibilities

• Lead all production activities, ensuring medical devices are produced efficiently, safely, and in full compliance with global regulatory standards.
• Minimize downtime, maximize throughput, and continuously optimize assembly operations.
• Manage manufacturing personnel to achieve daily production targets.
• Ensure all manufacturing processes adhere to FDA regulations and ISO 13485 quality standards by enforcing company Work Instructions (WIs) and Standard Operating Procedures (SOPs).
• Maintain individual LOT documentation via device history records (DHR).
• Recruit, train, and mentor production technicians, working with the Quality team to maintain quality standards and track defect rates.
• Collaborate with Engineering team to implement Lean manufacturing principles and process optimization strategies to increase yield, reduce waste, and enhance efficiency.
• Coordinate closely with Supply Chain to ensure raw material availability, with Quality Assurance to resolve non-conformances, and with Engineering for new product scale‑ups.
• Manage the end‑to‑end manufacturing process of medical products, ensuring they are produced safely, efficiently, and in strict compliance with regulatory standards such as FDA and ISO 13485, while achieving production Key Performance Indicators (KPIs).