NPI Staff Engineer, Medical Device Manufacturing

Insulet Corporation; Iskandar Puteri; Sur place; MYR 180 000 - 300 000; Plein temps

Avantages offerts par ce poste

Competitive package

Career growth opportunities

On-site role

Résumé du poste

Insulet Corporation is seeking an experienced NPI Staff Engineer to drive new product introductions and transfers in our Malaysia facility. You will lead engineering builds, qualification efforts, and validation activities, coordinating with Operations, Quality, R&D, and Supply Chain to ensure robust manufacturing readiness and scalable performance.

You will apply structured problem-solving, project management, and risk management to improve yield, reduce cost, and support ramp-up in a

Qualifications

• B.S. degree and 8+ years in medical device engineering.
• Strong PM and cross-functional leadership experience.
• IQ/OQ/PQ execution and validation documentation experience.
• Knowledge of FDA 21 CFR Part 820, ISO 13485 and cGMP.
• English and Mandarin fluency is a plus.

Responsabilités

• Lead NPI programs, product transfers, and projects through lifecycle.
• Lead equipment qualification and process validation activities (IQ/OQ/PQ).
• Collaborate with Operations, Quality, R&D, Supply Chain, and external partners.
• Drive CAPA and continuous improvement to improve quality and efficiency.
• Maintain cGMP compliance with FDA/ISO requirements.

Connaissances

Project management

Cross-functional leadership

IQ/OQ/PQ execution

Risk management

DMAIC Six Sigma

Mandarin fluency

Cleanroom manufacturing

Formation

B.S. degree in Mechanical/Electrical/Industrial engineering

Outils

PFMEA

DMAIC

Six Sigma Green Belt

Description du poste

Insulet Corporation is seeking an experienced NPI Staff Engineer to drive new product introductions and transfers in our Malaysia facility. You will lead engineering builds, qualification efforts, and validation activities, coordinating with Operations, Quality, R&D, and Supply Chain to ensure robust manufacturing readiness and scalable performance.

You will apply structured problem-solving, project management, and risk management to improve yield, reduce cost, and support ramp-up in a