Job Description
An NPI Engineer is required to work with our client on a 12-month contracting position. This role involves working collaboratively with cross-functional project teams to develop robust product designs, ensuring capable manufacturing processes.
Key Responsibilities:
* Develop device prototypes to support characterization and validation.
* Work with suppliers and incoming inspection laboratories to ensure appropriate inspection methods and controls are in place for components and finished devices.
* Identify project risks and develop mitigation strategies to ensure supply, quality, and timelines are met.
* Monitor supplier performance and provide technical support to resolve issues.
Requirements:
* Mechanical or Biomedical Engineering degree or equivalent.
* A minimum of 4 years' experience in medical device design and development, including design with SolidWorks, prototyping, testing.
* Prior experience in medical device process design and/or manufacturing is highly desirable.
* Experience in executing validation of equipment or processes, including preparation of protocols and reports (OQ/PQ).
* Understanding of product lifecycle and validation requirements for a new product introduction.