Engineer, Test

JOB RESPONSIBILITIES

. Develops and conducts test plans and protocols for design verification, process characterization, process validation, finished product and benchmarking study to generate test reports with sound engineering principle.

. Design, develop, and implement automated and manual test procedures for functional, performance, and regression testing.

. Identifies and consolidates requirement lists from product performance, functional and regulatory aspects

. Drives the entire design verification and validation activities to ensure compliance to regulatory requirements such as IEC, FDA, GMP, ISO and IEC standards.

. Develops and executes various benchmark testing to understand product quality compared to existing products

. Develops and validates new equipment and fixtures to conduct various testing.

. Conducts feasibility testing together with product development and quality team

. Liaise with external test labs to obtain critical data for test reports.

. Work with equipment vendors to identify test equipment that meets testing requirements.

. Participate in Risk Management and Failure Analysis exercises such as FMEA (Failure Mode & Effects Analysis).

. Identify, document, and track defects using issue tracking tools.

. Work closely with development teams to identify and address potential issues early in the development lifecycle

. Communicate all identified risks to your Test/Team Lead

. Summarizes test report and present to project and management team.

. Perform other tasks as assigned by the supervisor.

JOB REQUIREMENTS

. Degree or Masters in Mechanical/Electrical/Bio Engineering or related field

EXPERIENCE

. Minimum 3-5 years relevant experience, preferably in Medical Device, Automotive or Aerospace industry.

. Knowledge and familiar with IEC60601 test and requirements.

SKILLS

. Strong in mechanical and electrical fundamentals.

. Good understanding of DOE (Design of Experiments) principles.

. Prefarably with six sigma green belt training