Design Verification Engineer – Medical Devices

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is seeking a Design Verification Engineer to join our expanding team in the East area.

You will develop verification plans, lead TRRs and collaborate with Engineering, Quality, Regulatory and Manufacturing to deliver robust test methods for medical device projects. The role requires a degree in Mechanical/Electrical/Mechatronics engineering and practical experience in design verification or validation, with familiarity with FDA and ISO 13485 standards being advantageous.

Qualifications

• Min Degree in Mechanical Engineering / Electrical Engineering/ Mechatronics Engineering or a related discipline.
• Relevant experience in medical device testing, design verification or validation.
• Familiar with regulatory requirements (FDA / ISO 13485) will be advantageous.
• Good communication and able to work with cross-functional teams.
• Detail-oriented, organised and able to manage multiple projects.

Responsibilities

• Work closely with Engineering, Quality, Regulatory and Manufacturing teams.
• Develop and implement design verification plans for medical device projects.
• Work with different teams to develop clinically relevant testing methods.
• Design, build and maintain test fixtures, jigs and equipment.
• Prepare test plans, methods, acceptance criteria and required documentation.
• Lead Test Readiness Reviews (TRR) and ensure all test equipment and samples are ready.
• Develop, validate and conduct test methods for product verification.
• Conduct design verification, reliability and life testing.
• Perform testing such as accelerated life testing and test-to-failure.
• Analyse test results and prepare verification and technical reports.
• Maintain proper traceability from design inputs to test results and reports.
• Support regulatory submissions and ensure compliance with relevant standards.
• Perform ad-hoc duties as assigned.

Skills

Cross-functional teamwork

Test planning

Documentation

Education

Bachelor's degree in Mechanical/Electrical/Mechatronics Engineering

Job description

Our client is one of the leading players in the medical devices manufacturing sector. Due to their current expansion plan, they are looking for a Design Verification Engineer to join their team, in hopes of developing the current high performing team. They are located in the East area.

Job Responsibilities:

• Work closely with Engineering, Quality, Regulatory and Manufacturing teams.
• Develop and implement design verification plans for medical device projects.
• Work with different teams to develop clinically relevant testing methods.
• Design, build and maintain test fixtures, jigs and equipment.
• Prepare test plans, methods, acceptance criteria and required documentation.
• Lead Test Readiness Reviews (TRR) and ensure all test equipment and samples are ready.
• Develop, validate and conduct test methods for product verification.
• Conduct design verification, reliability and life testing.
• Perform testing such as accelerated life testing and test-to-failure.
• Analyse test results and prepare verification and technical reports.
• Maintain proper traceability from design inputs to test results and reports.
• Support regulatory submissions and ensure compliance with relevant standards.
• Perform ad-hoc duties as assigned.

Requirements:

• Min Degree in Mechanical Engineering / Electrical Engineering/ Mechatronics Engineering or a related discipline.
• Relevant experience in medical device testing, design verification or validation.
• Familiar with relevant medical device quality and regulatory requirements (such as FDA / 1SO 13485) will be advantageous.
• Good communication and able to work with cross-functional teams.
• Detail-oriented, organised and able to manage multiple projects.

We regret that only shortlisted candidate will be notified.