Director, Operations Inhealth Technologies

Freudenberg Sealing Technologies S.a.s. di Externa Italia S.r.l.u.; Carpinteria (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Freudenberg Group in Carpinteria, CA leads manufacturing operations across the site to meet safety, quality, delivery, cost and continuous improvement targets. You will oversee planning, performance management, and development of an Operations team across multiple shifts.

Collaborate with Product Development, Quality, Regulatory and Finance to ensure readiness and alignment with business objectives; drive lean initiatives, ensure compliance with ISO 13485, FDA, EU MDR, and manage budgets and

Qualifications

• Bachelor's degree or higher in Engineering, Operations, or Business.
• 10+ years of manufacturing operations experience, including at least 5 years in a senior leadership role.
• Deep knowledge of global regulatory requirements (FDA, ISO 13485, EU MDR, CFDA).
• Proven success leading multi-shift teams in a regulated production environment.
• Strong budgeting, CAPEX management, and financial acumen.

Responsibilities

• Lead all manufacturing operations for the site, including production, scheduling, and support functions to meet 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.

Skills

Lean manufacturing

Regulatory knowledge

Budget management

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree in Engineering, Operations, or Business

Tools

SAP

Microsoft Office

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 sciences, or other regulated industries.

Physical Requirements

• 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.

The expected salary range for this position is $120,000 to $150,000 annually, depending on skills, experience, and qualifications.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC