Sean Tan, MBA, MASC

Lead manufacturing strategy and operations for regulated medical device products supporting commercial production and development activities. Responsible for scalable, compliant manufacturing across Cocoon systems, software-enabled manufacturing deliverables, medical tubing assemblies, cassettes, and accessories, with focus on operational performance, automation, organizational capability, and commercialization readiness. Scope of responsibility: • Manufacturing strategy, scale-up, and operational execution • Cocoon system, software, consumables, and device assembly manufacturing • Commercial and development manufacturing support • Cross-functional leadership across engineering, quality, supply chain, and software teams • Workforce development, operational excellence, and continuous improvement

Led manufacturing operations for medical device production, overseeing production strategy, automation initiatives, workforce development, and operational performance. Key achievements: • Delivered 50% production scale-up while maintaining quality and regulatory compliance. • Accelerated 2× capacity expansion, completing the initiative within 9 months ahead of the original 2026 timeline. • Led automation transformation, converting manual medical tubing assembly into a robotic automated manufacturing process. • Established operational KPIs to track quality, efficiency, and service performance across manufacturing operations. • Directed workforce planning, budgeting, and staffing strategy to support production growth. • Led cross-functional collaboration with engineering, quality, and clients on product changes and manufacturing validation. • Supported IQ/OQ/PQ validation processes for regulated medical device manufacturing systems. • Built a culture of continuous improvement through team engagement, coaching, and structured feedback. Operational Scope • Medical device manufacturing operations • Production automation and process transformation • Manufacturing scale-up and capacity expansion • Cross-functional engineering and quality collaboration • Workforce development and operational leadership

- Completed research project focusing on developing a hard and flexible transparent coating, with effective time management and project planning, despite COVID-19-related laboratory capacity restrictions.

- Directed cross-functional global teams to deliver strategic product and regulatory initiatives, ensuring alignment with business objectives across multiple regions. - Orchestrated end-to-end project execution, including scope definition, resource planning, risk mitigation, and performance tracking to consistently meet cost, timeline, and quality targets. - Drove root cause analysis and implemented corrective actions to resolve complex operational and product-related challenges. - Led high-impact global programs spanning new product development, competitive benchmarking, trademark and regulatory compliance, product branding, and lifecycle (shelf-life) management. - Managed critical, time-sensitive initiatives in response to global market disruptions and regulatory shifts, including supply chain realignment during the US–China trade war, compliance transitions related to BREXIT, and evolving requirements from the Korea Occupational Safety and Health Agency (KOSHA). - Spearheaded international product transfer projects across internal and external manufacturing sites, ensuring continuity of supply and regulatory adherence. - Acted as a proactive escalation point, identifying risks early and mobilizing stakeholders to implement timely solutions. - Served as Internal Auditor for ISO 9001 and ISO 17025, reinforcing compliance and continuous improvement across operations.

- Led end-to-end execution of strategic operational initiatives, driving alignment across manufacturing, quality, and supply chain functions to deliver business-critical outcomes. - Directed a USD $5.5M Center of Excellence Transformation Program spanning two unionized manufacturing sites (~1,000 employees), enhancing operational performance across OEE, quality, planning & scheduling, workforce capability, and technology investment. - Optimized resource allocation and project prioritization frameworks, improving execution efficiency and on-time delivery across multiple concurrent initiatives. - Partnered with senior leadership to navigate complex operational challenges, applying data-driven decision-making and structured problem-solving to achieve targets within tight timelines and budget constraints. - Established governance cadence through executive-level reporting and cross-functional reviews, proactively identifying risks and driving timely mitigation strategies. - Fostered a culture of continuous improvement and accountability by engaging stakeholders at all levels, from shop floor teams to senior management. - Served as Internal Auditor for ISO 9001 and ISO 17025, as well as Health & Safety standards, strengthening compliance and operational discipline.

- Built and scaled the Process Engineering function from the ground up, establishing and leading a high-performing team of 13 engineers to support site-wide operational excellence. - Championed a data-driven quality culture by implementing InfinityQS and embedding Statistical Process Control (SPC) methodologies across manufacturing operations. - Drove enterprise-level process and quality improvement programs, leveraging Six Sigma and Operational Excellence frameworks to enhance product consistency, reduce variation, and improve yield. - Led cross-functional problem-solving initiatives in partnership with Quality, including Gauge R&R, structured root cause analysis, 8D investigations, customer complaint resolution, and material review board governance. - Directed product transfer and validation programs across manufacturing lines, ensuring seamless scale-up, regulatory compliance, and production readiness. - Expanded and modernized laboratory capabilities, increasing capacity and enabling advanced technical diagnostics to support manufacturing and quality assurance. - Orchestrated cross-functional continuous improvement initiatives, aligning engineering, quality, and operations teams to deliver sustained performance gains. - Served as Internal Auditor for ISO 9001 and ISO 17025, as well as Health & Safety and operational excellence standards, reinforcing compliance and governance.

- Led 24/7 manufacturing operations across multiple product lines, including rubber insulating gloves (RIG), household, and industrial gloves, ensuring consistent delivery on quality, volume, cost, and schedule targets. - Managed and developed a workforce of ~300 employees, driving performance through strong frontline leadership, accountability, and capability building. - Implemented Lean manufacturing principles to optimize workflows, reduce waste, and improve overall equipment effectiveness and product quality. - Fostered a culture of continuous improvement and operational discipline, embedding structured problem-solving and employee engagement at all levels of the organization. - Directed cross-functional and cross-site initiatives to enhance operational alignment, resource utilization, and best practice sharing across manufacturing facilities. - Ensured compliance with quality, laboratory, and safety standards as Internal Auditor for ISO 9001, ISO 17025, Health & Safety, and 5S, reinforcing governance and operational excellence.

- Produced Rubber Insulating Gloves and Sleeves at the best quality, delivered to customers at the right quantity, time and cost. - Led a team of 100 employees and managed 24/7 manufacturing activities in the RIG Plant - Improved glove quality, increased efficiency and/reduced costs. - Developed and managed standard operating procedures, work instructions and training materials. - Drove daily production activities with effective communication and leadership. - Managed continuous improvement initiatives to drive gains in quality, flow and output. - Developed RIG in-house formulation. - Internal auditor for ISO 9001, ISO 17025, health & safety, 5S.

- Commissioned and led the startup of a new manufacturing facility for ASTM D1051 rubber insulating sleeves, establishing operational readiness from concept through full-scale production. - Directed 24/7 plant operations, leading a team of 30 employees to achieve production, quality, and safety targets in a greenfield environment. - Implemented Statistical Process Control (SPC) systems and data analytics to drive process stability, quality performance, and continuous improvement. - Spearheaded the development and commercialization of the world’s first ASTM D1051 rubber insulating sleeve produced using a water-based dipping process, advancing product innovation and sustainability. - Partnered cross-functionally with finance, supply chain, and marketing to define product costing, budgeting, go-to-market strategy, and successful product launch execution.

- Accounted for 24/7 operations activities and led a team of 60 employees. - Managed P&L, production, material and shipment planning; enforcement of health and safety policies; risk assessment, equipment maintenance, process improvement, quality and workforce. - Led Operational Excellence and CAPEX Projects. - Prepared budgets, financial statements and written reports on production matters. - Oversaw productions, quality control and maintenance departments.

- Conducted design and research of new products. - Evaluated and validated new and alternative materials and processes. - Performed pilot run and transferred products from laboratory to commercial production. - Wrote protocols, qualification documents, test plans and test reports for quality assurance purposes. - Internal auditor for ISO 9001 and ISO 17025. - Developed coefficient of friction test for rubber film surface.

Dean Certificate Award - 7th Semester, 2006 Dean Certificate Award - 8th Semester, 2007