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Senior Manufacturing Engineer

CooperSurgical · Alajuela

Senior 🇬🇧 English
Six Sigma Green Belt Excel SolidWorks MiniTab Microsoft Word Equipment qualification Process validation

Description du poste

About the role

CooperSurgical seeks a Senior Manufacturing Engineer to lead complex equipment and process validation projects, support product transfers, and drive continuous improvement across its manufacturing operations.

Key responsibilities

  • Execute engineering assignments such as ECNs, NPEs, and LCNs independently.
  • Manage product transfers and acquisitions through the PTR/PAR process.
  • Integrate R&D products and validate complex equipment and manufacturing lines.
  • Own specific equipment for preventive maintenance, calibrations, and investigation of EIRs/MIRs.
  • Partner with Value Stream Teams to ensure capacity, minimize scrap, and improve labor efficiency.
  • Ensure compliance with FDA, OSHA, ISO, and corporate regulations.
  • Assist equipment technicians in troubleshooting and define improvement programs for cost, quality, and capacity.
  • Collaborate with technical operations to modify part designs for better manufacturability.
  • Maintain a continuous‑improvement mindset and support management initiatives.

Required profile

  • Engineering degree (mechanical, electrical, chemistry, biomedical, microbiology or related).
  • 5‑10 years of experience in a labor‑ and machine‑intensive manufacturing environment.
  • Strong project‑management knowledge; PMP preferred.
  • Deep understanding of equipment qualification and process validation.
  • Experience with lab and chemistry equipment (weighing scales, mixing processes, steam sterilizers) is a plus.
  • Six Sigma Green Belt (Black Belt preferred) and solid Lean principles.
  • Fluent in English and Spanish.

Required skills

  • Project Management (PMP)
  • Six Sigma Green Belt / Black Belt
  • Lean Manufacturing
  • Excel
  • SolidWorks
  • MiniTab
  • Microsoft Word & PowerPoint
  • FDA GMP compliance
  • Equipment qualification and process validation
  • Operation of weighing scales, mixing equipment, steam sterilizers

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CooperSurgical

Alajuela