Test Engineer

·         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.