Test Engineer

Epsilon Medical Devices; Selama (Perak); On-site; MYR 36,000 - 50,000; Full time

Job summary

A leading medical device manufacturing company seeks a Testing Engineer to spearhead testing processes and improve product testability. The ideal candidate will have at least 3 years of experience in testing and knowledge of ISO standards, contributing to the continuous improvement of manufacturing activities.

Qualifications

• Minimum 3 years of experience in testing.
• Knowledge of Quality Systems (ISO 9001, 13485) required.
• Experience in medical device manufacturing is an advantage.

Responsibilities

• Provide technical support for medical device testing and develop NPI test fixtures.
• Analyze and repair defective products.
• Create and update documentation related to testing procedures.

Skills

Problem-solving

Communication

Interpersonal

Resource Management

Analytical Skills

Education

Degree in Engineering

Tools

Microsoft Excel

Job description

· Fully responsible for providing technical support for medical device testing, developing NPI test fixtures and test programs and maintaining related test equipment and test fixtures, etc.

· Lead test processes includes burn-in, functional test, electrical safety test, aging test, troubleshooting and other necessary test processes for medical device manufactured.

· Actively involve in medical device product test line setup (develop and integrate the test platform).

· Test fixtures and test program development work.

· Analyze and repair the defective products.

· Create and update documentation related to testing procedures, test cases, test scripts, and other documents creation, revision control and maintenance.

· Work with design team to improve testability of new products and provide the test feedback for improving design for manufacturability.

· Be responsible for achieving key indicators such as FPY and down time/rework time.

· Work with manufacturing team to contribute to operation excellence, continuous improvement and corporation goal making.

· Conduct process validation (IQ, OQ, PQ), software validation and preparation of related documents together with manufacturing and quality team according to ISO 13485 standard.

· Continuous improvement on production activity that related to testing, rework, debug and troubleshoot.

· Update PM and Quality Dept, and host internal teams to solve issue and share ideas.

· Involve in quotation for testing aspects.

· Closely liaise with buyers on testing requirement before and after purchase of equipment.

· Preparation for audit ISO 13485 and ISO 9001 in term of documentation and production floor readiness.

Job Requirements

Degree in Engineering with a minimum of 3 years of experience in testing.

Experience working with multiple functions/levels of the organization.

Relevant skillset knowledge of Quality System like ISO 9001, 13485.

Will be advantage experience in manufacturing industries (e.g.: medical device assembly, PCBA and molding)

Computer literate and good in Microsoft especially M. Excel as well as presentation skills for reports.

· Well sense of responsibility and used to work under pressure.

· Proven track record of production. Highly skilled in communication, interpersonal, problem-solving, resource management and allocation.

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Manufacturing, Transport & Logistics 51-100 employees

We are an established ISO 9001 and ISO 13485 Certified Medical Device Manufacturing Company. We specialise in manufacture and assembly of plastic injection molded and extruded components for medical applications.

We are an established ISO 9001 and ISO 13485 Certified Medical Device Manufacturing Company. We specialise in manufacture and assembly of plastic injection molded and extruded components for medical applications.