NPI Staff Engineer — Medical Device Manufacturing & Validation

Insulet Corporation; Gelang Patah; On-site; MYR 180,000 - 240,000; Full time

Job summary

Insulet Corporation in Malaysia (Johor) seeks an NPI Staff Engineer to drive new product introductions and transfers, ensuring manufacturing readiness and regulatory compliance. You will lead engineering builds, validations, and CAPA initiatives across cross-functional teams including Operations, QA, R&D, and Supply Chain.

The role emphasizes structured problem-solving, project management, and cost improvements to support ramp-up and ongoing operational excellence in a cGMP environment.

Qualifications

• 8+ years in medical device engineering.
• Experience with IQ/OQ/PQ documentation.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong cross-functional project leadership.

Responsibilities

• Lead NPI programs, product transfers, and engineering projects through all phases.
• Coordinate engineering builds, validation, and manufacturing readiness.
• Drive CAPA, risk management, and quality improvements.
• Collaborate with Operations, Quality, R&D, Supply Chain, and external partners.

Skills

Project management

Problem-solving

Communication

Cross-functional collaboration

DMAIC

Six Sigma Green Belt

Multilingual English Mandarin

Education

B.S. in Engineering

Tools

IQ/OQ/PQ execution

PFMEA

Job description

Insulet Corporation in Malaysia (Johor) seeks an NPI Staff Engineer to drive new product introductions and transfers, ensuring manufacturing readiness and regulatory compliance. You will lead engineering builds, validations, and CAPA initiatives across cross-functional teams including Operations, QA, R&D, and Supply Chain.

The role emphasizes structured problem-solving, project management, and cost improvements to support ramp-up and ongoing operational excellence in a cGMP environment.