NPI Manager - MENICON SINGAPORE PTE. LTD.

Roles & Responsibilities

Menicon is a contact lens specialist embracing precision craftsmanship to see life in detail. Join our family in Singapore, the first manufacturing facility outside Japan for daily disposable contact lens and a base for developing technologies and products with advanced, value-added features.

Reporting to the Senior Manager for Operations, the NPI Manager leads a team of engineers in process development, product improvements, validation and will be the key liaison with Japan headquarters on new product development.

Responsibilities :

• Lead initiatives to enhance product performance, manufacturability and cost effectiveness
• Identify and implement process improvements to increase yield, reduce variation, and ensure consistent quality in manufacturing.
• Oversees validation for processes and products, including OQ / PQ
• Lead validation efforts for software and digitized processes, including ERP system, electronic records etc
• Ensure compliance to ISO13485, FDA and other regulatory requirements (eg : FDA 21 CFR Part 11)
• Manage end to end new product development projects from feasibility through launch
• Facilitate and ensure alignment across global teams eg : R&D, Marketing, Regulatory, Quality, Supply Chain
• Lead and ensure robust design control documentation

Requirements :

Tell employers what skills you have

Negotiation

Management Skills

Leadership

FDA

Analytical Skills

Quality Assurance

Process Validation

Strategy

Computer System Validation

Compliance

Project Management

Product and Production Engineering

Design Control

Product Development

Regulatory Requirements

Manufacturing