NPI Engineer

A well-established global company specializing in the development and manufacturing of miniature components for the medical device industry. Their work focuses primarily on laser processing, cutting, drilling, and welding.

The role-

• Leading NPI (New Product Introduction) projects from product design to full implementation on production lines
• Managing validation processes and ensuring compliance with international quality and regulatory standards
• Overseeing cross-functional teams and coordinating collaboration across departments
• Integrating innovative technologies in the medical device and pharmaceutical fields
• Managing production launches and line transfers
• Driving process improvements and operational efficiency

Requirements-

• BSc in Mechanical Engineering, Biomedical Engineering, Industrial Engineering and Management, Chemistry, or a related field
• 8+ years of experience leading NPI projects
• Experience in the pharmaceutical or medical device industry
• Hands-on experience performing process and equipment validations (IQ/OQ/PQ)
• Familiarity with quality and regulatory standards such as ISO 13485, GMP, and FDA QSR – an advantage
• High proficiency in English – spoken, written, and reading