Description This position is responsible for leading all production activities, ensuring medical devices are produced efficiently, safely, and in full compliance with global regulatory standards. This role minimizes downtime, maximizes throughput, and continuously optimizes assembly operations, while managing manufacturing personnel to achieve daily production targets. Regulatory Compliance: Ensure all manufacturing processes adheres FDA regulations and ISO 13485 quality standards by enforcing company WIs (Work Instructions) and SOPs (Standard Operating Procedures). In addition, maintains individual LOT documentation via device history records (DHR). Team Leadership: Recruit, train, and mentor production technicians in working with Quality team to maintain company’s quality standards and track defect rates. Continuous Improvement: Collaborate with Engineering team to help implement Lean manufacturing principles and process optimization strategies to increase yield, reduce waste, and enhance efficiency. Cross-Functional Collaboration: 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. Position is primarily responsible for managing 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). Requirements Education: Bachelor’s degree in Industrial / Mechanical Engineering, Operations Management, or a related field is preferred; or a minimum of +8 years of progressive experience in medical Class II device manufacturing. Production Scheduling: Execute production schedules to meet customer demand and sales forecasts. Manage manufacturing budgets, track scrap and rework rates, and control operational costs. Technical proficiency: Strong managerial capabilities with deep understanding of medical device manufacturing documentation (i.e. DHR), knowledge of Design Controls, understanding of GMP (Good Manufacturing Practices), and an understanding of process engineering. Certifications: Certifications such as GMP/ISO standards, PMP (Project Management Professional), Lean Certified, or Six Sigma Black/Green Belt are highly preferred. Standing/sitting for long periods of time (3-4 hours) and lifting packages up to 50 lbs.