NPI Staff Engineer - Medical Devices Manufacturing

Insulet Corporation; Malaysia; On-site; MYR 180,000 - 300,000; Full time

Job summary

Insulet Malaysia Sdn. Bhd. in Johor Bahru seeks an NPI Staff Engineer to lead New Product Introduction programs and engineering projects across the lifecycle, including design transfers, validation, and manufacturing readiness.

You will collaborate with Operations, Quality, R&D, and Supply Chain to drive process improvements, ensure regulatory compliance (FDA/ISO 13485/cGMP), and support high-volume manufacturing ramp-up. Strong problem-solving and project management are essential.

Qualifications

• Education and Experience: B.S. and 8+ years of medical device experience, preference in Mechanical, Electrical, or Industrial engineering.
• Strong project management skills with experience leading cross-functional NPI, technology transfer, equipment qualification, and process validation projects, including planning, execution, risk management, and delivery of results within established timelines.
• Experience with IQ/OQ/PQ execution and validation documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, cGMP, and risk management methodologies including PFMEA.
• Excellent understanding of structured problem-solving tools (e.g. DMAIC, Six Sigma Green Belt).
• Multi-language fluency (English and Mandarin minimum).
• Work experience at high-volume manufacturing line in cleanroom environment.

Responsibilities

• Report to the Senior Manager, NPI & Test Engineering and provide technical leadership, coaching, and mentoring to engineers and technicians.
• Lead and support New Product Introduction (NPI) programs, product transfers, and assigned engineering projects throughout the project lifecycle, including concept development, planning, qualification, validation, implementation, manufacturing readiness, production ramp-up, and sustaining support.
• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate cross-functionally with Operations, Quality, Manufacturing Engineering, R&D, Supply Chain, and external partners to support project execution and manufacturing objectives.
• Lead continuous improvement initiatives by utilizing structured problem-solving methodologies to investigate product, process, equipment, and manufacturing issues and implement effective corrective and preventive actions (CAPA) to improve quality, yield, equipment performance, and operational efficiency.
• Lead risk identification, assessment, and mitigation activities throughout NPI, validation, and production transfer projects using PFMEA, risk assessments, and structured risk management methodologies.
• Maintain a cGMP-compliant environment and ensure compliance with FDA, ISO 13485, and company Quality System requirements.
• Monitor project, quality, and operational metrics and drive actions required to achieve established performance targets.
• Author and review engineering documentation including validation protocols, reports, investigations, work instructions, SOPs, engineering assessments, and risk management documentation.
• Perform other duties as assigned.

Skills

Project management

Quality systems

Problem solving

English & Mandarin

Education

B.S. in Mechanical Engineering

Job description

Insulet Malaysia Sdn. Bhd. in Johor Bahru seeks an NPI Staff Engineer to lead New Product Introduction programs and engineering projects across the lifecycle, including design transfers, validation, and manufacturing readiness.

You will collaborate with Operations, Quality, R&D, and Supply Chain to drive process improvements, ensure regulatory compliance (FDA/ISO 13485/cGMP), and support high-volume manufacturing ramp-up. Strong problem-solving and project management are essential.