R&D Test Engineer - Medical Devices

About the role

Fongs is looking for an R&D Test Engineer to support product testing, design verification and validation, working closely with the 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.

Required profile

• 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 cybersecurity requirements for medical device testing.
• Strong problem-solving and stakeholder communication skills.

Required skills

• Design of Experiments and statistical analysis software such as Minitab.
• Test automation tools and scripting languages.

Candidates apply by sending their CV directly to Fongs on LinkedIn, highlighting their medical device testing and validation experience.