Head of Operations Engineering
Oxenham Group
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:
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Vacancy posted 3 days ago
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