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Insulet

Designs and manufactures tubeless insulin pumps

Director, Manufacturing - Manufacturing Operations

Manufacturing & Production OperationsConfirmed live in the last 24 hours
Full-timeCosta RicaNo salary listed

About the Job

Requirements

  • A bachelor's degree in Engineering, Manufacturing, Operations, Business, or a related discipline is required; a master's degree or MBA is preferred.
  • At least 10 years of progressive experience in high-volume manufacturing or operations is required; medical devices or another regulated industry experience is preferred.
  • At least 7 years of leadership experience with responsibility for manufacturing managers, supervisors, technical partners, and production teams is required.
  • Experience launching or significantly expanding a greenfield manufacturing operation is preferred.
  • 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 is strongly preferred.
  • Working knowledge of FDA-regulated manufacturing, ISO 13485 quality systems, Good Manufacturing Practices, and production-control disciplines is preferred.
  • Capability in Lean manufacturing, Six Sigma, daily management, structured problem solving, workforce planning, and performance improvement.
  • Financial acumen and experience managing operating budgets, labor plans, productivity, cost performance, and capital priorities.
  • Ability to work in a Class 8 cleanroom environment as needed and maintain regular presence in manufacturing areas.
  • Ability to stand and walk up to five hours a day.
  • Ability to flex the work schedule regularly to provide shift coverage as business demands require.
  • For the additional Malaysia plant description, a bachelor's degree in Operations or Engineering, or experience in a related field, is specified as a minimum; a combination of education, training, and experience demonstrating competency may be substituted.
  • The additional Malaysia plant description requires 12 years of field experience and at least five years of management experience with direct manufacturing experience in a regulated industry.
  • Preferred capabilities in the Malaysia plant description include knowledge of safety compliance with state, federal, and local regulations and manufacturing operations and quality-control assurance best practices; ability to analyze data using operating systems and programs, develop intra-department teams, set goals, and take corrective actions; financial management and business acumen.
  • The Malaysia plant description also prefers strong verbal and written communication and analytical and problem-solving skills.

Responsibilities

  • Establish strategic priorities, governance, accountability, and daily operating mechanisms for the Costa Rica greenfield manufacturing organization.
  • 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 key performance indicators 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 with cross-functional teams.
  • Ensure adherence to applicable quality-system, regulatory, environmental, health, safety, and company requirements; promote a 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, operating expenses, cost-per-unit performance, productivity, forecasts, and corrective actions.
  • Establish tiered accountability, escalation, and performance-review processes to create visibility into risks, actions, owners, and results.
  • Foster an inclusive, engaged, and accountable workplace where employees 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.
  • Establish manufacturing strategy, priorities, operating standards, governance, and site performance expectations.
  • 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.
  • For the Malaysia plant, coordinate plant activities and monitor procedures and standards to deliver consistent high-quality products efficiently.
  • Support general plant safety, Good Manufacturing Practices, and regulatory compliance.
  • Plan and direct operations and establish production and manufacturing priorities based on process and cost factors.
  • Direct purchasing and procurement in coordination with production, maintenance, and quality control to optimize production and use of resources, machines, and equipment.
  • Review and analyze production, quality-control, maintenance, and operational reports to identify causes of nonconformity with product specifications and operating or production problems.
  • Develop and implement operating methods and procedures to eliminate operating problems and improve product quality.
  • Foster continuous improvement in products, service, and processes to reduce waste and improve efficiency and profitability.
  • Ensure compliance with safety and work rules and regulations.
  • Apply Lean concepts, lead the sustainability process, and drive continuous improvement using problem-solving methodology.
  • Perform other duties as assigned.

Desired Qualifications

  • Preferred experience in medical devices or another regulated industry.
  • Proven direct accountability for launching or significantly expanding a greenfield manufacturing operation.
  • Experience with highly automated, discrete-component assembly and cross-functional manufacturing support organizations.
  • Working knowledge of FDA-regulated manufacturing, ISO 13485 quality systems, Good Manufacturing Practices, and production-control disciplines.
  • The Malaysia plant description prefers knowledge of safety-related regulatory compliance and manufacturing operations and quality-control assurance best practices; ability to analyze data using operating systems and programs, build intra-department teams, set goals, and take corrective actions; and strong financial management and business acumen.

About the Company

Insulet

Designs and manufactures tubeless insulin pumps

Insulet develops insulin delivery systems for diabetes. Its flagship Omnipod is a tubeless, waterproof insulin pump that delivers continuous insulin, controlled by a wireless handheld device and using disposable pods. The company also offers Omnipod 5, an automated insulin delivery system that works with continuous glucose monitors to adjust dosing. Insulet differentiates itself with a tubeless design and global manufacturing and distribution, aiming to make insulin delivery more convenient and autonomous for users.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Acton, MA
Founded
2000

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