Lead all manufacturing operations for the site, including production, scheduling, and support functions, to achieve safety, quality, delivery, cost, and continuous improvement targets.
Oversee department-level planning, goal setting, and performance management across multiple shifts or production units.
Direct and develop an Operations team to ensure strong leadership pipeline and succession planning.
Collaborate with SBU functional leaders of Product Development, Quality, Regulatory and Finance to ensure operational readiness and alignment with business objectives.
Drive operational excellence through lean manufacturing, process improvement initiatives, and employee engagement programs.
Ensure compliance with global regulatory and quality standards, including ISO 13485, FDA, EU MDR, and other applicable country-specific requirements.
Lead operational input into site-level budget planning, cost management, and capital investments.
Monitor and report on operational KPIs and recommend actions to improve output, quality, efficiency, and customer satisfaction.
Bachelor’s degree in Engineering, Operations, or Business required.
10+ years of experience in manufacturing operations, with at least 5 years in a senior leader capacity.
Deep knowledge of global regulatory requirements (e.g., FDA, ISO 13485, EU MDR, CFDA).
Proven success leading multi-shift teams in a regulated production environment.
Advanced business and financial acumen with experience managing operational budgets and CAPEX projects.
Strong cross-functional leadership, decision-making, and stakeholder management skills.
Proficiency in ERP (SAP preferred), Microsoft Office, and data-driven performance management.
The expected salary range for this position is $130,000 to $150,000 USD annually, depending on skills, experience, and qualifications.
