Lead Group Ireland are currently seeking an NPI Engineer to join a Medical Device company in Galway. This is an exciting opportunity to work in a dynamic and fast-paced medical device environment, supporting the introduction of new products and process improvements. The successful candidate will play a key role in product transfers, project management, and validation activities.
Key Responsibilities:
* Lead New Product Introduction (NPI) activities from concept to full-scale production.
* Manage and coordinate product transfers into manufacturing.
* Plan, execute, and document validation activities (IQ, OQ, PQ) in compliance with industry standards.
* Work closely with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain.
* Identify and implement process improvements to enhance efficiency and product quality.
* Ensure all projects adhere to regulatory requirements and company policies.
* Provide technical support and problem-solving expertise for new and existing products.
Key Requirements:
* Degree in Engineering (Mechanical, Biomedical, Manufacturing, or a related discipline).
* Minimum of 3 years’ experience in an NPI, Manufacturing, or Process Engineering role within the Medical Device industry.
* Strong experience with validation protocols (IQ, OQ, PQ).
* Demonstrated ability in project management and working with cross-functional teams.
* Experience in product transfers and process optimization.
* Knowledge of regulatory requirements (ISO 13485, FDA, GMP) is a plus.
* Excellent problem-solving, communication, and organizational skills.
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