Director, Manufacturing Operations
MedTechPharmaRegulatory AffairsQuality Assuranceemafdaiso 13485croraveinform
Job description
Job Summary Director, Manufacturing COSTA RICA • MANUFACTURING OPERATIONS LOCATION Costa Rica WORK ARRANGEMENT On-site REPORTS TO VP, Manufacturing Operations TRAVEL Up to 25%, including international travel Position Overview The Manufacturing organization is responsible for delivering safe, compliant, reliable, and efficient production while achieving the site’s safety, quality, service, cost, and people objectives. The Director, Manufacturing is the senior operations leader responsible for establishing and leading manufacturing operations at the Costa Rica site. This role directs production execution, operational readiness, manufacturing performance, workforce capability, and continuous improvement while partnering with Engineering, Quality, Supply Chain, Finance, Human Resources, and Global Operations. The Director is accountable for building a high-performing manufacturing organization and operating system that consistently delivers customer demand, product quality, regulatory compliance, cost performance, and employee engagement. The successful candidate combines strong manufacturing leadership, disciplined execution, financial acumen, talent development, and cross-functional influence. Key Responsibilities Provide strategic and operational leadership for the Costa Rica greenfield manufacturing organization, establishing clear priorities, governance, accountability, and daily operating mechanisms. Lead safe, compliant, reliable, and efficient production to achieve site objectives for safety, quality, service, cost, delivery, and people. Build, lead, coach, and develop manufacturing leaders and production teams; establish workforce plans, training systems, succession plans, and organizational capability for plant start-up, ramp, and steady-state operations. Develop and execute production plans that align labor, equipment, materials, and support resources with customer demand and business priorities. Own manufacturing KPIs and management routines, including output, schedule attainment, equipment utilization, process yield, line efficiency, labor productivity, scrap, downtime, and cost performance. Partner with Manufacturing Engineering, Quality, Supply Chain, Planning, Finance, Human Resources, IT, Facilities, and Global Operations to ensure production readiness and resolve operational constraints. Lead new production-line start-ups, capacity expansion, technology transfer, product introductions, and manufacturing scale-up in collaboration with cross-functional teams. Ensure adherence to applicable quality-system, regulatory, environmental, health, safety, and company requirements; promote a strong culture of quality and compliance. Drive structured, data-based problem solving and continuous improvement using Lean, Six Sigma, standard work, visual management, root-cause analysis, and mistake-proofing methods. Own the manufacturing operating budget and partner with Finance on labor planning, OPEX, cost-per-unit performance, productivity, forecasts, and corrective actions. Establish effective tiered accountability, escalation, and performance-review processes that create visibility to risks, actions, owners, and results. Foster an inclusive, engaged, and accountable workplace where employees are empowered to identify problems, improve processes, and deliver high-quality results. Represent Manufacturing in site leadership and global cross-functional forums; communicate performance, priorities, risks, and resource needs to executive leadership. Perform other duties and lead additional business initiatives as required. Education & Experience Bachelor’s degree in Engineering, Manufacturing, Operations, Business, or a related discipline required; master’s degree or MBA preferred. 10+ years pf progressive experience in high-volume manufacturing or operations, preferably in medical devices or another regulated industry. 7+ years of leadership experience with responsibility for manufacturing managers, supervisors, technical partners, and production teams. Preferred: proven experience for direct accountability for launching or significantly expanding a greenfield manufacturing operation. Demonstrated success leading plant start-up, manufacturing ramp, capacity expansion, technology transfer, or major operational transformation. Experience with highly automated, discrete-component assembly and cross-functional manufacturing support organizations strongly preferred. Working knowledge of FDA-regulated manufacturing, ISO 13485 quality systems, Good Manufacturing Practices, and production-control disciplines preferred. Demonstrated capability in Lean manufacturing, Six Sigma, daily management, structured problem solving, workforce planning, and performance improvement. Strong financial acumen with experience managing operating budgets, labor plans, productivity, cost performance, and capital priorities. Excellent communication, change-leadership, talent-development, analytical, and cross-functional influence skills. Key Decision Rights Establish manufacturing strategy, priorities, operating standards, governance, and performance expectations for the site. Allocate manufacturing resources and adjust production priorities within delegated authority to protect safety, quality, delivery, and cost objectives. Recommend workforce, technology, capacity, and capital investments based on business demand, operational risk, and financial return. Initiate containment, escalation, and corrective-action processes when safety, quality, compliance, delivery, or cost performance is at risk. Approve manufacturing improvement initiatives, organization plans, and operating mechanisms aligned with site and Global Operations requirements. Required Leadership, Interpersonal Skills & Behaviors Strategic thinker who can align supplier capabilities with business and technical objectives. Strong communicator and collaborator across manufacturing, engineering, quality, supply chain, finance, and people teams. Proven ability to lead, develop, and mentor high-performing manufacturing organizations. 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 and maintain regular presence in manufacturing areas. Role is based in Costa Rica and requires a minimum of four days per week in the office. Domestic and international travel may be required up to 25% based on business needs. 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

 Job Title: Director, Manufacturing Department: Manufacturing Operations FLSA Status: Nonexempt Position Overview: The Director, Manufacturing, will be responsible for the coordination of activities for the Malaysia Manufacturing Plant in Johor. The candidate in this role will monitor procedures and standards to deliver consistent high-quality product
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