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Project Engineer (Clean & Pack)

Careers at Fastnet
Cork
Chantelle Morrissey
Contract
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Job Reference: JO-2403-66636_1711377617

Summary:

Project Engineer (Clean & Pack)

12 Month Contract

Cork

Our medical device client based in Cork is looking for a Project Engineer to join their team!

Position Summary

The Project Engineer will plan and execute clean and packaging activities to deliver the next generation of Joint Reconstruction medical devices. The role is part of a cross functional team developing advanced manufacturing processes and ensure flawless introduction of new products to the site. Collaborating with global clean and packaging functions, the position will be responsible for ensuring optimum design for manufacturability of new products being introduced to the site.

Responsibilities

  • Technical execution of process development activities relating to clean and packaging aspects of NPI and technology development projects.
  • Manage risk management and validation lifecycle for new process or process changes.
  • Direct PFMEA studies and lead risk assessment effort for overall process.
  • Influence innovative qualification and validation techniques based on statistical assessment, failure model and overall risk .
  • Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ/SMA).
  • Design, develop and source tools, fixtures and special equipment for clean and pack processes.
  • Liaise with supplier quality to complete supplier product and process verification process for pack components

Requirements

  • Bachelor's degree in Engineering is required
  • Demonstrated validation experience
  • Experience in Medical Devices or regulated industry with demonstrated GDP and technical writing skills
  • Self-motivated, with focus on Quality, Service, Growth and Cost

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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