Job Description
An NPI Engineer is required by Careerwise recruitment to work with our Galway based client on a 12-months contracting position.
Role of this position
1. Work collaboratively with cross-functional project teams to develop robust product design to ensure capable manufacturing processes.
2. Build and Assess device prototypes to support characterization.
3. Work on manufacturing line/pilot line with external suppliers to characterize and validate new and improved manufacturing processes and components.
4. Work with suppliers and incoming inspection laboratories to develop, validate and ensure appropriate inspection methods and controls are in place for components and finished devices.
5. Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
6. Monitor supplier performance and provide technical support to resolve issues.
JOB REQUIREMENTS
7. Mechanical or Biomedical Engineering degree or equivalent.
8. A minimum of 4 years' experience in medical device design and development (including design with SolidWorks, prototyping, testing).
9. Prior experience in medical device process design and or manufacturing is highly desirable.
10. Experienced in executing validation of equipment or processes, including preparation of protocols and reports. (OQ/PQ).
11. Understanding of product lifecycle and validation requirements for a new product introduction.