R&D Test Engineer – Medical Devices

Beecruit Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Fongs is seeking an R&D Test Engineer to support product testing, design verification and validation, working closely with Development, Quality and Regulatory teams.

Hands-on experience in medical device product testing and validation is essential. The role involves developing test plans, executing manual and automated tests, and coordinating with external labs and vendors.

Qualifications

• Hands-on experience in medical device testing and validation.
• Develop and execute test plans for design verification and validation.
• Design and implement manual and automated test procedures.
• Coordinate with external test laboratories and equipment vendors.
• Strong problem-solving and stakeholder communication skills.

Responsibilities

• Develop and execute test plans and protocols for design verification, process validation and product performance.
• Design and implement manual and automated test procedures.
• Conduct feasibility, functional, performance and benchmark testing.
• Analyse test results and prepare technical reports.
• Develop and validate test equipment and fixtures.
• Manage laboratory equipment, calibration and qualification activities.
• Support compliance with applicable regulatory requirements and standards.
• Coordinate with external test laboratories and equipment vendors.

Skills

Design of Experiments

Regulatory knowledge

Statistical analysis

Test execution

Problem solving

Stakeholder communication

Education

Engineering degree

Master's degree

Tools

Minitab

Scripting languages

Test automation tools

Job description

Fongs is seeking an R&D Test Engineer to support product testing, design verification and validation, working closely with Development, Quality and Regulatory teams.

Hands-on experience in medical device product testing and validation is essential.

Key Responsibilities

• Develop and execute test plans and protocols for design verification, process validation and product performance.
• Design and implement manual and automated test procedures.
• Conduct feasibility, functional, performance and benchmark testing.
• Analyse test results and prepare technical reports.
• Develop and validate test equipment and fixtures.
• Manage laboratory equipment, calibration and qualification activities.
• Support compliance with applicable regulatory requirements and standards.
• Coordinate with external test laboratories and equipment vendors.

Candidate Requirements

• Three to five years of relevant experience, including hands-on medical device product testing and validation.
• Degree or Master's in Mechanical Engineering, Electrical Engineering, Materials Science, Bioengineering or a related discipline.
• Strong knowledge of verification and validation methodologies, regulatory requirements and technical documentation.
• Understanding of Design of Experiments and proficiency in Minitab or similar statistical analysis software.
• Proficiency in test automation tools and scripting languages.
• Understanding of cybersecurity requirements for medical device testing.
• Strong problem-solving and stakeholder communication skills.