Job Summary:
New Product Introduction (NPI) Project Manager
We are seeking an experienced New Product Introduction (NPI) project manager to lead and manage the successful transition of new products into manufacturing within the medical device space.
This is a critical role that requires a strong understanding of NPI processes, quality systems, and regulatory requirements. The ideal candidate will have experience in managing NPI projects from concept through to production ramp-up, collaborating with cross-functional teams, and ensuring robust product and process development.
* Lead and Manage NPI Projects:
* Develop and implement effective NPI strategies to ensure timely and successful product launches.
* Collaborate with design, quality, and manufacturing teams to ensure robust product and process development.
* Manage project timelines, budgets, and resources to ensure successful project delivery.
* Collaborate with Cross-Functional Teams:
* Work closely with design, quality, and manufacturing teams to ensure seamless handoffs and efficient communication.
* Ensure that all stakeholders are aligned and informed throughout the project lifecycle.
Requirements:
* Bachelor's degree in Engineering or related field.
* Minimum 3 years of experience in a regulated manufacturing or product development environment.
* Experience in NPI, process development, or design transfer projects.
* Strong understanding of validation protocols (IQ/OQ/PQ), risk management, and quality systems (ISO 13485/FDA).
* Excellent communication and project coordination skills.
Benefits:
* Opportunity to work on high-profile NPI projects.
* Collaborative and dynamic work environment.
* Professional growth and development opportunities.