Senior Operations Director — Medical Device Manufacturing

Sterling Engineering; Libertyville (IL); Presencial; USD 190.000 - 195.000; Tempo integral

Benefícios oferecidos por esta vaga

Annual bonus (15%)

401(k) with company matching

Paid time off

Resumo da vaga

Sterling Engineering is seeking an experienced Operations Director to lead a high-volume, highly automated medical device manufacturing operation in Libertyville, IL. This senior role focuses on drug-delivery devices production, including epinephrine auto-injectors, for pharmaceutical customers.

The ideal candidate will have a strong background in regulated, high-volume manufacturing, with expertise in automation, precision assembly, injection molding, and Lean principles.

Qualificações

• Bachelor's degree in Engineering, Manufacturing, Operations Management, Business, or a related field.
• 10+ years of progressive manufacturing leadership experience, including senior operations management.
• Strong experience in high-volume medical device manufacturing, preferably involving automated assembly, injection molding, or drug delivery devices.
• Experience leading large, complex manufacturing operations in FDA-regulated or similarly controlled environments.
• Demonstrated success managing manufacturing performance, operational budgets, cost reduction initiatives, and P&L responsibilities.
• Strong understanding of automated manufacturing equipment, manufacturing engineering, and production process optimization.
• Proven experience implementing Lean Manufacturing principles and driving measurable continuous improvement results.
• Experience managing cross-functional manufacturing teams and developing supervisors, managers, and technical leaders.
• Strong knowledge of manufacturing KPIs, production planning, capacity management, and operational efficiency.
• Excellent leadership, communication, problem-solving, and organizational skills.
• Ability to operate effectively in a fast-paced, high-volume manufacturing environment.

Responsabilidades

• Provide strategic and day-to-day leadership for high-volume medical device manufacturing operations, ensuring production, quality, delivery, and financial objectives are consistently achieved.
• Oversee manufacturing operations and supporting functions, including Manufacturing Engineering, Maintenance, Production Planning, Supply Chain, and Logistics.
• Lead production activities involving highly automated manufacturing equipment, precision assembly, and injection molding processes.
• Drive operational performance through improvements in productivity, throughput, equipment utilization, labor efficiency, and cost management.
• Establish and monitor KPIs related to safety, quality, delivery, cost, and operational efficiency.
• Manage operational budgets, staffing requirements, financial performance, and P&L responsibilities.
• Partner closely with Engineering, Quality, and Validation teams to ensure manufacturing processes meet regulatory requirements and customer expectations.
• Champion Lean Manufacturing and continuous improvement initiatives utilizing 5S, Kaizen, Kanban, Value Stream Mapping, and other operational excellence methodologies.
• Lead process optimization and manufacturing improvement initiatives to reduce downtime, improve yields, and increase production capacity.
• Develop and mentor manufacturing leaders, supervisors, and technical teams while fostering a culture of accountability, collaboration, and continuous improvement.
• Support manufacturing growth, new product introductions, equipment installations, and production ramp-up activities.
• Collaborate with senior leadership on strategic planning, operational objectives, and long-term manufacturing initiatives.
• Maintain strong customer relationships and participate in operational reviews to ensure customer commitments are consistently met.
• Ensure compliance with applicable FDA, GMP, quality, environmental, and workplace safety requirements.

Conhecimentos

High-volume medical device

Lean manufacturing

Regulatory compliance

P&L budgeting

Cross-functional leadership

Problem-solving

Leadership and mentorship

Process optimization

Injection molding

Formação

Bachelor's degree in Engineering/Manufacturing/Operations Management/Business

10+ years manufacturing leadership experience

Ferramentas

Automation equipment knowledge

Quality systems familiarity

Descrição da vaga

Sterling Engineering is seeking an experienced Operations Director to lead a high-volume, highly automated medical device manufacturing operation in Libertyville, IL. This senior role focuses on drug-delivery devices production, including epinephrine auto-injectors, for pharmaceutical customers.

The ideal candidate will have a strong background in regulated, high-volume manufacturing, with expertise in automation, precision assembly, injection molding, and Lean principles.