Senior Test Engineer, Medical Devices Validation & Automation

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

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.