Research and Development Engineer

The successful candidate will contribute to the development of regulated medical devices while collaborating with software, firmware, quality, regulatory, and clinical stakeholders throughout the product development life cycle.

Key Responsibilities

Product Development

• Support the design and development of innovative medical devices from concept through verification and validation.
• Define and document product requirements and technical specifications.
• Participate in prototype development, integration, and performance testing activities.
• Support product design reviews and technical risk assessments.
• Troubleshoot and resolve technical issues during development.

Electronics & Systems Engineering

• Contribute to the development of electronics-based medical devices.
• Work closely with software and firmware teams to ensure successful system integration.
• Support hardware evaluation and performance characterisation activities.
• Assist in system architecture and requirements management activities.

Verification & Validation

• Develop and execute test protocols.
• Perform product verification and validation activities.
• Analyse test results and generate technical reports.
• Ensure traceability between requirements, risks, and testing activities.

Regulatory & Quality

• Support medical device design control processes.
• Participate in risk management activities.
• Assist with technical documentation required for MDR and FDA compliance.
• Work within ISO 13485 quality management systems.

Project Support

• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Clinical Affairs, and Manufacturing.
• Coordinate with external suppliers and development partners.
• Support project planning and achievement of development milestones.

Requirements

• Degree in Electrical Engineering, Biomedical Engineering, Medical Technology, Electronics Engineering, Mechatronics, or similar discipline.
• Previous experience within medical device product development or regulated R&D environments.
• Experience developing electronics-based products.
• Understanding of product development life cycles and design controls.
• Experience working with multidisciplinary engineering teams.
• Strong problem-solving and communication skills.

Preferred Experience

• Medical device development.
• Electronics and embedded systems.
• Wearable technologies.
• Neuromodulation or neurotechnology products.
• Digital health platforms.
• Verification & Validation activities.
• MDR and FDA regulated environments.
• Startup or innovation-driven projects.