Junior Systems Engineer (DDx), DxD Hub

Agency for Science, Technology and Research (A*STAR); Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A leading research agency in Singapore is seeking a System Engineer focused on software development for Software as a Medical Device (SaMD). The role involves supporting project management, assisting in product development, and ensuring compliance with regulatory standards. Ideal candidates will have a background in computer or biomedical engineering and experience in software development.

Qualifications

• At least one year of experience in software development or medical device product development.
• Educational background in computer engineering or biomedical engineering.
• Experience in a software development environment is advantageous.

Responsibilities

• Support project managers in planning and executing SaMD projects, including AI applications.
• Assist in product development, design verification, and validation of medical devices.
• Prepare documentation collaboratively with developers and regulatory personnel.

Skills

Software development

Knowledge of ISO 13485

Strong follow-up skills

Education

Bachelor's in Computer Engineering

Bachelor's in Biomedical Engineering

Job description

JOB DESCRIPTION

This role focuses on software development for Software as a Medical Device (SaMD). The system engineer will work closely with project managers and teams to ensure the thorough management of the SaMD product lifecycle.

Responsibilities include:

1. Supporting project managers in planning and executing SaMD projects, including AI applications in healthcare.
2. Assisting the technical team in product development, design verification, and validation of medical devices, including software components.
3. Preparing, designing, and developing documentation collaboratively with software developers, quality, and regulatory personnel.
4. Preparing project agreements, procurement specifications, and technical documents.
5. Monitoring project milestones and progress.

JOB REQUIREMENTS

• Preferably at least one year of experience in software development or medical device product development.
• Educational background in computer engineering or biomedical engineering.
• Knowledge of software development; experience in a software development environment is advantageous.
• Willingness to learn and apply ISO 13485 documentation practices and lead project teams in compliance.
• Strong follow-up skills.