Manufacturing Project Engineer

Manufacturing Project Engineer (12-Month Contract)

Location: County Cork, Ireland

Company Overview: A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment.

Key Responsibilities:

• Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes.
• Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems.
• Change Control: Oversee and support change control processes, ensuring proper documentation and approval.
• Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams.
• Documentation: Maintain clear documentation for validation, change control, and project progress.

Required Skills and Experience:

• 3+ years of experience in medical device manufacturing, including regulatory compliance and validation.
• Strong knowledge of FDA, ISO 13485, and EU MDR regulations.
• Experience in change control processes and project task execution.
• Excellent attention to detail, communication, and problem-solving skills.
• Ability to work in a cross-functional team and manage multiple priorities.

Contract Duration: 12 months, with potential for extension.

Application Process: Please submit your CV and cover letter outlining relevant experience.