Director, Manufacturing Engineering

Job description

Job Summary Director, Manufacturing Engineering COSTA RICA • MANUFACTURING ENGINEERING LOCATION Costa Rica WORK ARRANGEMENT On-site REPORTS TO VP, Manufacturing Operations TRAVEL Up to 25%, including international travel Position Overview Manufacturing Engineering enables safe, compliant, reliable, and efficient production through equipment engineering, process engineering, maintenance, facilities engineering, industrial engineering, automation, validation, and technical continuous improvement. The Director, Manufacturing Engineering is the senior technical leader for the Costa Rica manufacturing site. This role builds and leads a multidisciplinary engineering organization supporting plant start-up and ongoing operations, including equipment and maintenance engineering, NPI and process engineering, test engineering, facilities engineering, industrial engineering, automation, and validation. The Director partners closely with Operations, Quality, Regulatory, Supply Chain, Global Engineering, Finance, IT, and external equipment integrators to deliver production readiness, equipment reliability, process capability, regulatory compliance, and strong financial performance. The successful candidate combines deep technical expertise with disciplined execution, talent development, and cross-functional leadership. Key Responsibilities Provide strategic and technical leadership for the greenfield site Manufacturing Engineering organization and establish clear priorities, governance, operating mechanisms, and performance metrics. Build, lead, coach, and develop multidisciplinary engineering teams supporting equipment, maintenance, NPI and process engineering, test engineering, facilities, industrial engineering, automation, and validation. Develop the project, resource, and hiring plans required to support plant start-up, production ramp, capacity expansion, and stable ongoing operations. Lead equipment design reviews, procurement, factory and site acceptance testing, installation, commissioning, qualification, process validation, and production-line start-up activities. Own engineering performance indicators for safety, quality, service, cost, equipment uptime, process yield, line efficiency, preventive maintenance, calibration, and project execution. Establish and continuously improve preventive maintenance, calibration, spare-parts, asset-management, and reliability strategies for manufacturing equipment and facilities. Drive structured, data-based problem solving using SPC, process capability, root-cause analysis, Lean, Six Sigma, and mistake-proofing methodologies. Ensure manufacturing equipment, processes, facilities, and documentation comply with applicable quality-system, regulatory, environmental, health, and safety requirements. Partner with Operations, Quality, Regulatory, Supply Chain, Global Engineering, Finance, IT, and external suppliers to resolve technical risks and deliver business objectives. Manage departmental CAPEX and OPEX, project budgets, resource allocation, cost improvement, and financial performance in partnership with Finance. Support MES, CMMS, ERP, and equipment-data integration as required for effective manufacturing operations and asset management. Build technical capability, succession plans, training systems, and a culture of accountability, inclusion, continuous improvement, and operational excellence. Perform other duties and lead additional projects as required. Education & Experience Bachelor’s degree in Manufacturing, Mechanical, Electrical, Industrial, or a related Engineering discipline required; master’s degree or MBA preferred. 10+ years of progressive experience in high-volume manufacturing, engineering, plant engineering, maintenance, automation, or related operations; medical-device experience strongly preferred. 7+ years of engineering leadership experience, including responsibility for building, developing, and leading multidisciplinary technical teams. Preferred: proven experience for direct accountability for launching or significantly expanding a greenfield manufacturing operation. Demonstrated experience with highly automated discrete-component assembly, equipment lifecycle management, production-line start-up, and manufacturing scale-up. Working knowledge of equipment qualification and process-validation methodologies, including FAT, SAT, TMV, IQ, OQ, and PQ. Experience in an FDA-regulated and ISO 13485 quality-system environment preferred. Experience with CMMS, MES, enterprise asset management, ERP integration, Lean manufacturing, Six Sigma, SPC, and process-capability analysis preferred. Strong financial management, business acumen, analytical problem-solving, communication, and cross-functional influence. Key Decision Rights Establish site Manufacturing Engineering strategy, priorities, standards, governance, and technical operating mechanisms. Approve engineering approaches for equipment reliability, maintenance, validation, process capability, and manufacturing readiness within delegated authority. Prioritize engineering resources and recommend capital investments based on safety, quality, service, cost, capacity, and risk. Escalate and mitigate technical, compliance, and operational risks that could affect production, product quality, or project delivery. Drive technology standardization, continuous improvement, and scalable engineering solutions aligned with global requirements. Required Leadership, Interpersonal Skills & Behaviors Strategic thinker who can align supplier capabilities with business and technical objectives. Strong communicator and collaborator across engineering, operations, finance, and supplier teams. Proven ability to lead, develop, and mentor high-performing technical teams. Ability to navigate ambiguity, create clarity, and drive execution in fast-paced, cross-functional environments. Demonstrated ability to influence decisions and outcomes across organizational boundaries. Ability to distill information, prioritize effectively, and escalate appropriately to site and Global Operations leadership. Commitment to continuous improvement, accountability, and disciplined project execution. Additional Information Able to work in a Class 8 cleanroom environment as needed. Role is based in Costa Rica and requires a minimum of four days per week in the office. Travel up to 25%, including international travel to suppliers and manufacturing sites. Physical Requirements Must be able to stand and walk up to 5 hours a day Must be able to flex work schedule regularly as the business demands – for shift coverage Insulet's Global Manufacturing Operations organization currently supports our third-party contractor, Flextronics, in China and is preparing to start-up its first Company owned US Manufacturing location in Acton, MA. Additionally, manufacturing operations expansion into Europe is part of our 5-year strategic plan. The Director role will support manufacturing continuous improvement activities in current plants in addition to supporting manufacturing start-up activities in Acton and any future expansion locations. This position will be the functional lead for all Global Manufacturing Engineering resources and activities and is a key leadership position in Insulet’s Global Operations efforts. Responsibilities: • Functional lead for the Global Manufacturing Engineering Team. • Global Engineering’s subject matter expert for the Pod device. • Take a lead role in supporting Global Engineering and Acton Manufacturing Team in all equipment and process validation activities including FAT, TMV, IQ, SAT, OQ and PQ • Ensure components and assemblies produced at scale meet all elements of design intent and meet automated equipment PQ standards. • Coordination of cross-functional resources and efforts necessary to achieve successful PQ goals for all new production line start-ups. • Coordination of cross-functional efforts to solve challenges related to manufacturing process losses requiring product and/or process improvements. •Provide expertise in automation processes in the manufacturing area. Future Responsibilities: Include: • Coordination of Global Operations work for DV builds. • Support Global Operations continuous improvement efforts, obsolescence programs, technology transfers and documentation • Support Global Engineering efforts on future DFM/Next Gen Pod design and development work. • Ensure standardization of all equipment and process related activities across all manufacturing operations. • Support manufacturing in development of key KPI’s and action planning to improve performance to achieve KPI goals. Education and Experience: Minimum Requirements: • Bachelor’s Degree in Engineering • 7+ years of management experience in a high-volume manufacturing environment, with at least 3+ years of departmental leadership. Preferred Skills & Competencies: • A combination of education, training and experience that results in demonstrated competency to perform the work may be substituted. • Prior plant / manufacturing line start up experience is a plus. • Experience in a regulated industry required, life sciences preferred. • Knowledge of safety related issues including compliance with State, Federal and Local regulations as well as knowledge of manufacturing operations/quality control assurance best practices. • The ability to analyze data using various operating systems and programs, and to develop intra-department teams to establish goals and take corrective actions to improve performance. • Experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team is preferred. • Strong verbal and written communication skills, Independent self-starter with highly developed analytical/ problem solving skills. Experience with continuous improvement tools and methods. • Track record of leading positive change Physical Requirements: • Domestic and international travel may be required up to 50% of the time. Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!