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Plant Manager – Medical Device Manufacturing

HumanizaRte CR SA · Cartago

Senior 🇬🇧 English
ISO 13485

Job description

About the role

We are seeking an experienced Plant Manager to lead the start‑up, operational launch, and long‑term growth of a new medical‑device manufacturing facility in Cartago, Costa Rica. This senior leadership position will shape the plant’s culture, drive operational excellence, and ensure compliance with stringent regulatory standards.

Key responsibilities

  • Plan, execute, and manage the full site start‑up and ramp‑up of production.
  • Establish and maintain a high‑performance culture focused on quality, safety, and continuous improvement.
  • Lead manufacturing transfers and scale processes while meeting ISO 13485, FDA, and CE requirements.
  • Oversee cross‑functional teams, including engineering, quality, supply chain, and finance.
  • Develop and control budgets, drive cost‑optimization initiatives, and report financial performance.
  • Travel internationally as needed to support global operations and stakeholder alignment.

Required profile

  • Proven experience leading manufacturing operations and site start‑ups in the medical‑device or related regulated industry.
  • Strong knowledge of medical‑device regulations (ISO 13485, FDA, CE).
  • Demonstrated success in operational excellence, process optimization, and business growth.
  • Experience managing cross‑functional, multicultural teams.
  • Fluency in English and Spanish.

Required skills

  • ISO 13485 compliance
  • FDA regulatory knowledge
  • CE marking expertise

What we offer

  • Opportunity to build a world‑class facility from the ground up.
  • Leadership role in a fast‑growing, innovative MedTech organization.
  • Competitive compensation package.
  • Dynamic, collaborative work environment with international exposure.

Questions fréquentes

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Published 3 months ago

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HumanizaRte CR SA

Cartago