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 *****, 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 *****, 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.