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Senior NPI Engineer

Randstad MalaysiaKuala Lumpur, Kuala Lumpur, Malaysia

1 day ago

Job description

About The Company

A global manufacturing partner specializing in the medical device and pharmaceutical sector, providing end-to-end solutions from design to commercial production.

About The Job

Manage NPI projects from initial customer requirements through to production readiness.
Translate customer needs into product specifications and technical requirements.
Design and validate tools, jigs, and fixtures for manufacturing processes (manual, semi-automated, and automated).
Support process cycle time analysis, line balancing, and efficiency improvements.
Prepare technical documentation, including BOMs, SOPs, inspection methods, and validation reports.
Provide production support through troubleshooting and process optimization.
Conduct validation and continuous improvement activities to ensure quality and compliance.
Train production teams on new processes and ensure effective knowledge transfer.

requirements

Bachelor's degree (or higher) in Engineering or Science.

Minimum 2 years of experience in manufacturing, preferably in the medical device industry.

Strong understanding of project management, product / process development, and statistical analysis.

Proficiency in CAD software (e.g., SolidWorks).

Knowledge of ISO 13485 and GMP is an advantage.

Proactive, adaptable, and detail-oriented.

Proficient with Microsoft Office applications.

The details above serve as a guideline for the position. If you meet the requirements and believe you are a good fit, we encourage you to submit your application.

Kindly note that due to the large number of applications, only shortlisted candidates will be contacted.

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Npi Engineer • Kuala Lumpur, Kuala Lumpur, Malaysia