Engineer, Test

Roles & Responsibilities

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

Tell employers what skills you have

Test Equipment
FDA
FMEA
Design of Experiments
Regression Testing
ISO
GMP
Aerospace
Electrical
Risk Management
Process Validation
Characterization
Benchmarking
Six Sigma
Failure Analysis