NPI Engineering Lead — Medical Devices Manufacturing

Insulet Corporation; Johor Bahru; On-site; MYR 180,000 - 260,000; Full time

Job summary

Insulet Corporation in Malaysia seeks an NPI Staff Engineer to drive new product introductions, design and process transfers, and validation activities. You will lead cross-functional teams, manage equipment qualification, and oversee CAPA and risk management to ensure quality and ramp-up readiness.

Reporting to the Senior Manager, NPI & Test Engineering, you will collaborate with Operations, Quality, R&D, and Supply Chain, ensuring compliance with FDA, ISO 13485, and cGMP requirements while

Qualifications

• BS degree and 8+ years of medical device experience.
• Strong project management skills leading NPI and tech transfers.
• Experience with IQ/OQ/PQ and validation documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, cGMP.
• Fluency in English and Mandarin.

Responsibilities

• Report to the Senior Manager, NPI & Test Engineering and lead engineers.
• Lead NPI programs, product transfers, and project lifecycles.
• Manage equipment qualification and process validation (IQ/OQ/PQ).
• Collaborate with Operations, Quality, R&D, and Supply Chain.
• Drive CAPA, risk management, and continuous improvement.
• Maintain cGMP compliance and document validation activities.
• Monitor metrics and deliver within timelines.

Skills

Project management

NPI programs

Cross-functional leadership

Risk management

Problem solving

DMAIC

Education

B.S. in Mechanical, Electrical or Industrial engineering

Tools

PFMEA

IQ/OQ/PQ

Job description

Insulet Corporation in Malaysia seeks an NPI Staff Engineer to drive new product introductions, design and process transfers, and validation activities. You will lead cross-functional teams, manage equipment qualification, and oversee CAPA and risk management to ensure quality and ramp-up readiness.

Reporting to the Senior Manager, NPI & Test Engineering, you will collaborate with Operations, Quality, R&D, and Supply Chain, ensuring compliance with FDA, ISO 13485, and cGMP requirements while