Join Alcon as an NPI/Validation Engineer to lead the new product introduction and validation processes for cutting-edge eye care and vision products, ensuring compliance and quality from design to production.

Overview

Alcon, a global leader in eye care, is seeking a skilled NPI/Validation Engineer to join our dynamic team in Mulgrave. In this role, you will play a pivotal part in bringing innovative vision products to market by overseeing new product introductions and validation activities.

Key Responsibilities

• Lead NPI projects from design transfer to full-scale production, coordinating with R&D, quality, and manufacturing teams
• Develop and execute validation plans, including process, equipment, and software validations
• Conduct risk assessments and ensure all products meet regulatory standards such as FDA, CE Mark, and ISO requirements
• Perform data analysis, root cause investigations, and CAPA implementation
• Support supplier qualification and audit activities
• Collaborate on design reviews and continuous improvement initiatives
• Document all validation activities in compliance with GMP and quality systems

Why Join Alcon?

Work on groundbreaking technologies that improve lives worldwide, with opportunities for career growth in a supportive environment.

• Bachelor's degree in Mechanical, Biomedical, or related Engineering field
• 3+ years of experience in NPI processes and validation engineering, preferably in medical devices or pharmaceuticals
• Strong knowledge of FDA regulations, ISO 13485, and validation protocols (IQ/OQ/PQ)\n- Proficiency in risk management (FMEA), statistical analysis, and test method validation
• Experience with design controls, process validation, and manufacturing support
• Excellent problem-solving skills and attention to detail
• Ability to collaborate cross-functionally in a fast-paced environment

• Competitive salary and performance-based bonuses
• Comprehensive health, dental, and vision insurance
• Generous paid time off and flexible working hours
• Professional development opportunities and tuition reimbursement
• Employee stock purchase plan and 401(k) matching
• Wellness programs and on-site fitness facilities
• Collaborative and innovative work culture