An NPI (New Product Introduction) engineer is a professional responsible for managing and overseeing the process of introducing new products into manufacturing. This role typically bridges the gap between product design and mass production. The NPI engineer's responsibilities include ensuring that the product design is manufacturable, testing production processes, troubleshooting issues, and coordinating with various teams like design, sales, engineering, quality, and manufacturing to ensure smooth product launches.

Key Responsibilities

·         Work closely with the design team to ensure that new products are designed for manufacturability, cost-effectiveness, and efficiency.

·         Collaborate with various teams such as design, operations, quality assurance, and logistics to ensure the product is ready for production.

·         Evaluate product technical requirements and help define technical specifications.

·         Help create prototypes for the new product, identify potential design or production issues, and test different manufacturing methods.

·         Develop and optimize manufacturing processes, ensuring they meet quality standards and can be scaled for production.

·         Coordinate testing of the product and production processes to verify that the product performs as intended.

·         Oversee the entire product lifecycle, from development to launch, ensuring smooth transitions between each phase.

·         Ensure the product is built to specifications and that it meets quality standards.

·         Address any issues that arise during the transition from prototype to mass production, including supply chain or assembly challenges.

·         Create and maintain documentation of processes, designs, and testing results, and provide regular updates to senior management.

·         Independently work through complex problems with some input from Senior colleagues.

·         Document technical specifications, product features, and updates.

·         Has experience in multiple development phases, including those guided by Design Controls requirements. Demonstrates familiarity and compliance with Quality SOPs.

·         Demonstrates a strong understanding of ISO 13485, sufficient to participate in an audit and/or guide coworkers.

·         Demonstrates a functional technical and clinical understanding of products being actively worked on. Demonstrates a developing breadth of technical process expertise.

·         Follows safety requirements.

Education & Skills:

• Bachelor’s degree in engineering (Mechanical, Manufacturing Preferred)
• Five years or more of related experience required in a manufacturing environment.
• 5-10 years' experience in the medical device design/development field.

• Proficient in Microsoft Office: MS Teams, Excel, PowerPoint, Outlook.
• Familiarity with ISO 13485
• Familiarity with Plastic Materials and Processes
• Foundational SolidWorks skills.

Work Environment:

Office setting

Manufacturing floor environments

Controlled temperature environments

Expected Hours of Work
This is a Full-Time Salary position required to work Monday through Friday, with occasional weekends.

Travel:

Up to 10%