Freudenberg Medical LLC
Director,Operations
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optimal for Director candidates.
“Director, Operations at Freudenberg Medical LLC. Skills: manufacturing operations, regulatory requirements, cross-functional leadership, operational budgets. Lead all manufacturing operations for the site. Oversee department-level planning, goal setting, and performance management”
What You'll Achieve.
achieve safety, quality, delivery, cost, and continuous improvement targets; ensure operational readiness and alignment with business objectives; improve output, quality, efficiency, and customer satisfaction
Industry & Context.
Frequent walking and standing in a manufacturing environment, Occasional lifting up to 30 pounds, Work in controlled manufacturing environments including cleanrooms and PPE/gowning areas, Ability to support occasional off-hours, weekend production needs, or emergency escalations
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Operations, or Business required, 10+ years of experience in manufacturing operations, 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, cross-functional leadership, decision-making, and stakeholder management skills, Proficiency in ERP (SAP preferred), Microsoft Office, and data-driven performance management
Nice to Have
Graduate Degree in Operations, Engineering, or or related field, Lean Six Sigma Black Belt certification, Experience in medical device, life sciences, or other regulated industries
What You'll Do.
Lead all manufacturing operations for the site
Oversee department-level planning
and performance management
Direct and develop an Operations team
Drive operational excellence through lean manufacturing
Ensure compliance with global regulatory and quality standards
Lead operational input into site-level budget planning
Monitor and report on operational KPIs
How You'll Work.
Team & Collaboration
Collaborate with SBU functional leaders of Product Development, Quality, Regulatory and Finance
Process & Methodology
CAPEX projects
Full Job Description
**Working at Freudenberg: We will wow your world!** # Responsibilities: * 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. # Qualifications: * 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. Preferred Qualifications * Graduate Degree in Operations, Engineering, or Business; or related field. * Lean Six Sigma Black Belt certification. * Experience in medical device, life
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