NPI Manager
2 weeks ago
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:
- Degree in Engineering, Material Science, Biomedical Engineering or related discipline.
- 8 years working experience in a pharmaceutical or medical device industry.
- Experience in manufacturing process development, validation
- Knowledge of ISO13485
- Strong leadership skills, with the ability to influence and drive results in cross-functional and global teams.
- Strong Project Management skills
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