Head of Operations Engineering – U.S.

Location: Charleston, South Carolina Area
Industry: Medical Device Manufacturing

A rapidly growing global medical device organization is seeking a Head of Operations Engineering to lead the engineering function supporting a highly automated, state-of-the-art U.S. manufacturing operation.

This leader will own the site's manufacturing engineering strategy, build and develop a highly technical engineering organization, and partner closely with Production, Quality, Supply Chain, R&D, and global engineering teams to support continued growth, automation, operational excellence, and new product introduction.

Key Priorities

Candidates should bring particularly strong experience in the following areas:

• 10+ years within medical device engineering/manufacturing, including significant experience inside a manufacturing facility
• 5+ years leading engineering or technical teams
• Strong hands-on understanding of injection molding and highly automated manufacturing environments
• Experience supporting automated assembly, packaging, and/or metal/spring-forming processes
• Deep knowledge of manufacturing equipment, process troubleshooting, maintenance/sustaining engineering, and complex technical problem solving
• Strong automation, digitalization, Industry 4.0, and advanced manufacturing experience
• Equipment/process qualification and validation
• Advanced Root Cause Analysis (RCA) and structured problem-solving capabilities
• Proven ability to build, mentor, and develop teams of highly specialized engineers and technical experts
• Experience leading CAPEX, equipment installation, commissioning, validation, and manufacturing scale-up

This is not purely a strategic leadership position. The organization is looking for a leader who understands the technical realities of a manufacturing floor and can guide teams through equipment, process, automation, reliability, and production challenges.

Responsibilities

Manufacturing & Engineering Leadership

• Develop and execute the site's long-term manufacturing excellence and operations engineering strategy
• Lead and develop a local team of manufacturing engineers and technical experts
• Ensure the organization has the appropriate engineering resources, technical capabilities, and skill sets to support both current production and future growth
• Serve as a technical and cultural mentor across engineering and manufacturing functions
• Establish a high-performance engineering culture focused on ownership, innovation, problem solving, and continuous improvement

Production & Technical Support

• Partner closely with Production, Quality, Supply Chain, and Development leadership to ensure timely and sustainable resolution of complex manufacturing issues
• Provide technical leadership for equipment and manufacturing process troubleshooting, optimization, modification, and sustaining activities
• Drive structured problem solving and Root Cause Analysis for equipment, process, design, and manufacturing challenges
• Improve manufacturing reliability, throughput, quality, and Overall Equipment Effectiveness (OEE)
• Lead engineering efforts involving manufacturing methods, equipment performance, process capability, and production efficiency

Automation & Advanced Manufacturing

• Lead technical activities associated with the design, development, build, installation, commissioning, validation, and sustaining of manufacturing equipment and automated systems
• Advance automation and digitalization initiatives throughout the facility
• Champion Industry 4.0 and Future Factory initiatives
• Identify opportunities to introduce emerging technologies that improve scalability, reliability, efficiency, and manufacturing performance
• Help future-proof the manufacturing operation through increasingly automated and data-driven systems

CAPEX & Manufacturing Expansion

• Partner with Manufacturing and Logistics leadership to identify manufacturing efficiency opportunities and required CAPEX investments
• Lead or support major equipment and manufacturing expansion projects
• Ensure automation, continuous improvement, and CAPEX programs are delivered on time and within budget
• Monitor engineering programs against strategic goals, timelines, technical requirements, and financial commitments

New Product Introduction

• Partner closely with R&D and product development teams on new product introductions and manufacturing scale-up
• Support the transition of products and processes from development into commercial manufacturing
• Introduce advanced manufacturing processes and automation while maintaining product quality, regulatory compliance, cost objectives, and customer timelines

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline, or equivalent relevant experience
• Minimum 10 years of relevant experience within medical device development, engineering, and/or manufacturing
• Significant experience working within a manufacturing-site environment
• Minimum 5 years of engineering or technical leadership experience
• Strong understanding of manufacturing technologies including:
  • Injection molding
  • Automated assembly
  • Automated packaging
  • Metal and/or spring forming
  • Automated manufacturing equipment and systems
• Experience within a regulated medical device manufacturing environment
• Strong understanding of regulations and quality requirements applicable to medical device manufacturing
• Experience with process and equipment qualification/validation
• Strong background in automation and manufacturing digitalization
• Advanced understanding of structured problem-solving and Root Cause Analysis methodologies
• Experience managing complex technical projects and manufacturing initiatives
• Demonstrated ability to lead, coach, and develop highly skilled engineering teams
• Highly organized, disciplined, and capable of managing multiple priorities within a fast-paced manufacturing environment

The Opportunity

This position offers the opportunity to play a significant role in the growth and technical development of a modern U.S. medical device manufacturing operation.

The organization offers:

• Competitive compensation
• Modern manufacturing facilities and advanced technologies
• Significant exposure to automation and next-generation manufacturing
• High-impact engineering and operational leadership responsibilities
• Collaboration with a global network of technical and manufacturing professionals
• Strong opportunities for continued professional and leadership development