Sterling Engineering Inc. Director of Operations (Medical Device Manufacturing) in Buffalo Grove, IL | 1315734142

Estimated Pay info	$49 per hour
Hours	Full-time
Location	Buffalo Grove, Illinois

Job Description

Director of Operations

Location: Buffalo Grove, IL (100% Onsite)
Compensation: Up to $200,000–$210,000 base salary + 15% annual bonus
Relocation Assistance: Available

Position Overview

We are seeking an experienced Director of Operations to lead manufacturing and operational activities at a high-volume, highly regulated medical device manufacturing facility. This individual will be responsible for driving operational excellence, improving manufacturing performance, and ensuring the efficient delivery of high-quality products while maintaining strict regulatory and customer requirements.

The ideal candidate brings extensive experience leading high-speed, high-volume manufacturing operations within the medical device industry, along with a demonstrated ability to support major pharmaceutical customers and manage complex customer relationships. This is a hands-on leadership position requiring strong business acumen, financial ownership, and the ability to develop high-performing teams while driving continuous improvement across the organization.

Reporting to the General Manager, the Director of Operations will oversee core manufacturing and operational functions, ensuring alignment with business objectives, customer expectations, and long-term growth strategies.

Key Responsibilities

Provide strategic and day-to-day leadership across manufacturing operations, ensuring production targets, delivery commitments, product quality, and cost objectives are consistently achieved.
Develop and execute operational strategies aligned with business objectives, annual operating plans, and long-term growth initiatives.
Establish operational KPIs, financial goals, and performance metrics while driving accountability throughout the organization.
Maintain full operational and P&L ownership, including budgeting, cost management, resource allocation, and financial performance.
Direct and oversee manufacturing, production planning and control, purchasing, manufacturing engineering, test engineering, maintenance, and logistics functions.
Drive operational excellence within high-speed, high-volume manufacturing environments, focusing on productivity, throughput, efficiency, and scalability.
Ensure manufacturing processes consistently meet FDA, ISO 13485, GMP, and other applicable regulatory and customer requirements.
Lead and support new product introductions (NPI), process validation (IQ/OQ/PQ), design transfers, and manufacturing process improvements.
Partner closely with Quality, Engineering, Supply Chain, and Regulatory teams to maintain product quality, compliance, and operational efficiency.
Develop and maintain strong relationships with key customers, including major pharmaceutical industry clients. Participate in quarterly business reviews and ensure operational performance aligns with customer expectations.
Establish and implement Lean manufacturing and daily management systems to improve productivity, reduce waste, and strengthen operational performance.
Lead multi-shift manufacturing operations while maintaining a strong focus on employee safety, product quality, and regulatory compliance.
Identify opportunities to scale manufacturing capabilities and capacity while maintaining consistent quality and patient safety standards.
Recruit, develop, and retain a strong operational workforce through effective leadership, coaching, and succession planning.
Regularly communicate operational performance, business results, and improvement initiatives to executive leadership.

Required Qualifications

Bachelor's degree in Engineering, Operations Management, Manufacturing, or a related field. MBA preferred.
10–15+ years of progressive manufacturing and operations leadership experience, including at least 3–5 years in a Director-level Operations role.
Strong background in medical device manufacturing is required.
Demonstrated experience leading high-speed, high-volume manufacturing operations, including automated assembly and validated manufacturing processes.
Experience supporting major pharmaceutical customers and managing relationships with demanding, high-profile customers within the pharmaceutical industry.
Strong knowledge of FDA regulations, ISO 13485, GMP requirements, and customer audits within regulated manufacturing environments.
Proven experience managing P&L responsibilities, operational budgets, financial performance, and cost improvement initiatives.
Experience leading NPI programs, process validation (IQ/OQ/PQ), and design transfers into manufacturing.
Demonstrated success implementing Lean manufacturing principles, daily management systems, and continuous improvement initiatives.
Experience overseeing multiple manufacturing and operational functions, including production, engineering, maintenance, planning, and supply chain.
Ability to lead multi-shift manufacturing teams and drive accountability across a large operational organization.
Strong cross-functional leadership, communication, problem-solving, and decision-making skills.

Leadership Profile

The successful candidate will be a humble, confident, persistent, and data-driven leader with the energy and determination to drive results. They should be comfortable operating in a fast-paced manufacturing environment, developing future leaders, and building a culture centered on accountability, collaboration, continuous improvement, and operational excellence.

This individual must balance strategic leadership with a hands-on approach to problem-solving and execution.

Director of Operations (Medical Device Manufacturing)

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