Lead Group Galway
1 day ago
Job title: New Product Introduction Engineer
Description
Join our team as an accomplished NPI Engineer and contribute to driving the successful introduction of new products and process improvements at our Medical Device company in Galway. As part of our dynamic team, you will shape the future of our organization.
Key Responsibilities:
* Lead New Product Introduction activities, ensuring alignment with business objectives and seamless integration with existing processes.
* Coordinate product transfers into manufacturing, guaranteeing on-time delivery and optimal resource allocation.
* Develop, execute, and document validation activities (IQ, OQ, PQ), adhering to industry standards and best practices.
* Cultivate strong relationships with cross-functional teams, facilitating collaboration and driving collective success.
* Analyze data to identify areas for process improvement, implementing changes to enhance efficiency and product quality.
* Ensure regulatory compliance and adherence to company policies, maintaining our reputation for excellence.
* Deliver technical support and expert problem-solving services for new and existing products, exceeding expectations.
Requirements:
* Degree in Mechanical, Biomedical, or related field of Engineering.
* Minimum 3 years' experience in NPI, Manufacturing, or Process Engineering within the Medical Device sector.
* Proven track record of developing and executing validation protocols (IQ, OQ, PQ), with a focus on quality and efficiency.
* Strong project management skills, with experience leading cross-functional teams and achieving project milestones.
* Familiarity with product transfers and process optimization, with excellent analytical and problem-solving abilities.
* Knowledge of regulatory requirements (ISO 13485, FDA, GMP) is highly beneficial.
* Superb communication, organizational, and problem-solving skills, with a passion for delivering exceptional results.
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