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11 дней назад

Director, Manufacturing Operations (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director, Manufacturing Operations (Medical Devices): Establishing and leading manufacturing operations for a regulated medical-device production site, with an accent on production readiness, operational performance, workforce capability, and continuous improvement. Focus on launching and scaling production lines, managing quality and compliance, optimizing cost and productivity, and building a high-performing manufacturing organization.

Location: Heredia, Costa Rica; the description also references a Malaysia manufacturing plant in Johor. The role is described as on-site, requires a minimum of four days per week in the office, regular presence in manufacturing areas, Class 8 cleanroom work as needed, and up to 25% domestic and international travel.

Company

hirify.global develops the Omnipod wearable insulin-delivery product platform to help patients live simpler, healthier lives.

What you will do

  • Establish and lead manufacturing operations, governance, priorities, and daily operating mechanisms for a greenfield production organization.
  • Direct safe, compliant, reliable, and efficient production while managing output, quality, delivery, cost, productivity, and workforce performance.
  • Build and develop manufacturing leaders and production teams through workforce planning, training systems, succession planning, and capability development.
  • Lead production-line start-ups, capacity expansion, technology transfer, product introductions, manufacturing ramp, and operational scale-up.
  • Partner with Engineering, Quality, Supply Chain, Finance, Human Resources, IT, Facilities, and Global Operations to resolve constraints and improve readiness.
  • Own manufacturing budgets, KPIs, corrective actions, performance reviews, and continuous-improvement initiatives.

Requirements

  • Bachelor’s degree in Engineering, Manufacturing, Operations, Business, or a related discipline; a master’s degree or MBA is preferred.
  • At least 10 years of progressive experience in high-volume manufacturing or operations, with 7 or more years leading manufacturing managers, supervisors, technical partners, and production teams.
  • Experience in regulated manufacturing, preferably medical devices, including FDA-regulated operations, ISO 13485, Good Manufacturing Practices, and production controls.
  • Demonstrated success with plant start-up, manufacturing ramp, capacity expansion, technology transfer, or major operational transformation.
  • Experience with Lean manufacturing, Six Sigma, structured problem solving, workforce planning, operating budgets, labor plans, productivity, and cost performance.
  • Ability to work on-site at least four days per week, maintain regular manufacturing-area presence, work in a Class 8 cleanroom as needed, and adjust the schedule for shift coverage.

Nice to have

  • Direct accountability for launching or significantly expanding a greenfield manufacturing operation.
  • Experience with highly automated, discrete-component assembly and cross-functional manufacturing support organizations.
  • Master’s degree or MBA.

Culture & Benefits

  • Performance-driven environment focused on customer expectations, quality, safety, compliance, and operational accountability.
  • Inclusive workplace where employees are encouraged to identify problems, improve processes, and deliver high-quality results.
  • Regular collaboration with site leadership, global operations, engineering, quality, supply chain, finance, and people teams.
  • Travel of up to 25%, including domestic and international travel, may be required based on business needs.

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