summary

kuala lumpur, wilayah persekutuan
RM5,000 - RM8,000 per month
permanent

specialism
manufacturing
sub specialism
research & development
reference number
91M0263416_3432726150370840097

job details

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.

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.

skills
no additional skills required
qualifications
no additional qualifications required
education
Bachelor Degree

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cheuyen yoo

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senior npi engineer (medical device).

job details

skills

qualifications

education

share this job.

the application process.

apply with randstad.

we’ll give you a call.

getting you registered.

compliance check.

reference and background check.

the perfect job for you.

the interview.

start your new job.

get in touch

cheuyen yoo

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