New Product Introduction Manager

Mercuri Urval; Klang City; On-site; MYR 120,000 - 180,000; Full time

Job summary

Mercuri Urval represents an international client in the medical devices sector to appoint an NPI Manager responsible for leading the NPI department in Malaysia. The role focuses on ensuring compliance with ISO 13485, GMP, and related regulatory standards while driving new product introductions and improvements.

The successful candidate will oversee technical support to manufacturing and sales, material evaluation, and cost-reduction initiatives, with emphasis on Lean Manufacturing and

Qualifications

• Degree in Engineering/Science/Technology or equivalent.
• Minimum 5 years in project management or R&D, preferably with moulding/assembly/automation.
• ISO 13485 environment and FDA 21 CFR Part 820/GMP knowledge preferred.
• Initiative, creativity and ability to work independently.
• Good written and spoken English and local language.

Responsibilities

• Oversee the New Production Introduction (NPI) department.
• Ensure compliance with ISO 13485, GMP, and product ISO standards.
• Initiate and manage new product development and improvements.
• Provide technical support to manufacturing and sales.
• Lead material investigation and evaluation.
• Support new customer technical requirements.
• Drive Lean Manufacturing implementation.
• Review change requests from suppliers and customers.

Skills

Project management

Regulatory knowledge

Initiative

Independence

Education

Bachelor's degree in Engineering/Science/Technology

Job description

Job title: NPI Manager

We are representing a international client in medical devices manufacturing and engineering sector to appoint a NPI manager to in charge of NPI department

Job Responsibilities:

• Oversee the New Production Introduction (NPI), Department.
• Taking the necessary action to ensure that the standards related ISO 13485, GMP, product ISO standards and other regulatory requirements are achieved at all times.
• Initiate/implement projects on new product and improvement /enhancement programmes on existing product in relation to:
• Technical Support to manufacturing and sales
• New material investigation & evaluation
• New customer technical support
• Manufacturing process development
• Validation and re-validation activities
• Process verification activities
• Cost reduction programmes
• Implementation of Lean Manufacturing
• Evaluate competitor products when applicable to new development and keep up to date with current changes in technology.
• Review and evaluate change requests from suppliers and customers.

Job Requirements:

• Degree in Engineering / Science / technology or equivalent
• At least 5 years' experience in project management / research & development preferably with experience in moulding, assembly and automation process.
• Preferably with working experience in a manufacturing environment that is ISO 13485 certified.
• Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.
• Initiative, creativity, resourcefulness and ability to work independently are essential.
• Good written and spoken English and local language