Engineer, Test

SG ENDOSCOPY PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

SG ENDOSCOPY PTE. LTD. is seeking a test engineer with 3–5 years of experience in medical devices to lead verification activities.

You will develop test plans and reports, drive the entire design verification process, and ensure regulatory compliance across IEC60601, FDA, GMP, and ISO standards. You will design automated and manual test procedures, collaborate with product development and QA teams, and liaise with external labs and vendors to collect essential data for informed decisions.

Qualifications

• Degree or Masters in Mechanical/Electrical/Bio Engineering or related field.
• 3–5 years of relevant experience in medical devices, automotive, or aerospace.
• Knowledge of IEC60601 test requirements.

Responsibilities

• Develops and conducts test plans and protocols for verification, validation, and benchmarking.
• Design, develop, and implement automated and manual test procedures.
• Identifies and consolidates requirement lists from performance, functional and regulatory aspects.
• Drives design verification and validation to meet IEC, FDA, GMP, ISO standards.
• Develops and executes benchmark testing to compare product quality.
• Develops and validates new equipment and fixtures for testing.
• Conducts feasibility testing with product development and quality teams.
• Liaises with external test labs to obtain critical data.
• Collaborates with vendors to identify suitable test equipment.
• Participates in Risk Management and FMEA.
• Identifies, documents, and tracks defects.
• Communicates risks to Test/Team Lead and summarizes test reports.

Skills

Mechanical fundamentals

Electrical fundamentals

DOE

Six Sigma Green Belt

Education

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

Job description

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