Operations Manager

Sterling Engineering; Libertyville (IL); On-site; USD 190,000 - 195,000; Full time

Benefits offered by this job

Annual bonus (15%)

401(k) with company matching

Paid time off

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

High-volume medical device

Lean manufacturing

Regulatory compliance

P&L budgeting

Cross-functional leadership

Problem-solving

Leadership and mentorship

Process optimization

Injection molding

Education

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

10+ years manufacturing leadership experience

Tools

Automation equipment knowledge

Quality systems familiarity

Job description

Operations Director – Medical Device Manufacturing

Salary: Up to $190,000–$195,000 + 15% Annual Bonus

Relocation: Available for the right candidate

Industry: Medical Device / Pharmaceutical Manufacturing

Position Overview

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

The ideal candidate will bring a strong background in high-volume medical device manufacturing, with experience managing complex production operations, advanced automation, precision manufacturing, and injection molding processes.

This is a senior-level leadership opportunity for someone who can drive operational excellence, develop high-performing teams, and support the growth of a highly regulated manufacturing operation.

Job Responsibilities

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 key performance indicators (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.

Required Qualifications

Bachelor's degree in Engineering, Manufacturing, Operations Management, Business, or a related field.

10+ years of progressive manufacturing leadership experience, including significant experience in 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.

Preferred Qualifications

Experience manufacturing medical devices used for pharmaceutical drug delivery, including auto-injectors or similar products.

Background in high-speed automated assembly and precision injection molding.

Experience supporting new manufacturing operations, production ramp-ups, or significant capacity expansions.

Familiarity with FDA regulations, ISO 13485, GMP, and medical device quality systems.

Engineering background with a strong understanding of manufacturing technology and equipment.

MBA or advanced degree in Engineering, Operations, or Business.

Experience leading Lean transformations and implementing structured manufacturing operating systems.

Competitive base salary up to $190,000–$195,000 annually.

15% annual bonus opportunity.

401(k) with company matching.

Paid time off and holidays.

Opportunity to lead and grow a high-volume medical device manufacturing operation.