My client is seeking a highly skilled and motivated NPI (New Product Introduction) Process Engineer to join their team in Galway. The NPI Process Engineer will play a critical role in bringing new medical devices from concept to production, ensuring that all products meet the highest standards of quality and performance.
Key Responsibilities:
- Responsible for process development and introduction of new medical devices, from concept through to production.
- Collaborate with cross functional teams to ensure seamless product transfers.
- Develop and optimise manufacturing processes to achieve targets.
- Create and maintain detailed process documentation, including process flow diagrams, work instructions, and validation protocols.
- Conduct process validations (IQ, OQ, PQ) and ensure compliance with relevant regulatory standards.
- Identify and implement process improvements to enhance product quality and manufacturing efficiency.
- Manage and coordinate project timelines, resources, and budgets to ensure on-time delivery of new products.
- Participate in risk assessments, root cause analysis, and corrective action activities related to process issues.
Skills & Qualifications:
- Bachelor's degree in Engineering-Mechanical, Biomedical, Manufacturing or a related field
- 3-5 years of experience in process engineering within the medical device industry.
- Experience with new product introductions, process development, and validation.
- Strong understanding of regulatory requirements and quality systems in the medical device industry.
- Excellent project management skills with the ability to handle multiple projects simultaneously.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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