NPI Operations Manager
This is an exceptional opportunity to take on a leadership role in the launch of new medical products. The ideal candidate will have experience in product development, manufacturing processes and quality assurance.
Key Responsibilities:
* Develop and oversee the implementation of new product introduction (NPI) projects from concept through to production ramp-up
* Collaborate with cross-functional teams to ensure robust product and process development, meeting regulatory requirements and company standards
* Lead the development of optimized manufacturing processes, ensuring scalability, cost-effectiveness, and compliance with quality standards
* Prepare validation plans, risk assessments, and design transfer documentation
* Support design for manufacturability (DFM) and continuous improvement initiatives
Requirements:
* Degree in Engineering or related discipline
* 5+ years of experience in regulated manufacturing or product development environment (medical devices, pharma, automotive)
* Experience in NPI, process development, or design transfer projects
* Strong understanding of validation protocols, risk management, and quality systems (ISO 13485/FDA)
* Excellent communication and project coordination skills