Biomedical Systems Engineer: Medical Device Integration

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

DxD Hub is seeking a Biomedical/Translational Systems Engineer in Singapore to design, develop, and test medical devices while ensuring regulatory compliance. You will translate clinical literature into design requirements, collaborate across hardware, software, and chemistry domains, and lead verification, validation, and documentation activities.

The role requires strong system architecture and integration skills, with experience in ISO 13485 and cross-functional teamwork.

Qualifications

• Experience or equivalent in system integration and innovation.
• Bachelor's Degree in Engineering or related field.
• Comfort in navigating uncertain situations without clear guidelines.
• Adaptability to changing work conditions and project requirements.
• 5–10 years in cross-functional product development with at least one full product development cycle.
• Track record of working effectively with diverse teams (engineering, design, marketing).
• Strong communication to summarize complex problems plainly.
• Knowledge of statistical tools for data analysis (Python/ Matlab) recommended.

Responsibilities

• Develop high-level system architectures that meet user requirements and design feasibility.
• Ensure components are compatible and integrable.
• Design and implement integration strategies and validate functions per design principles.
• Lead collaborative teams for design, implementation, and validation; hands-on testing when needed.
• Create innovative solutions aligning with technical specs and user needs for medical products.
• Coordinate between design, engineering, assay, project management, and other disciplines.
• Author or oversee protocols and reports.
• Maintain technical documentation ensuring ISO 13485 compliance.
• Co-manage project execution with the Project Manager: own the technical workplan and milestones.

Skills

System integration

Cross-functional teamwork

Verification & Validation

Regulatory standards

Medical device design

Education

Bachelor's Degree in Engineering

Tools

ANSYS

Job description

DxD Hub is seeking a Biomedical/Translational Systems Engineer in Singapore to design, develop, and test medical devices while ensuring regulatory compliance. You will translate clinical literature into design requirements, collaborate across hardware, software, and chemistry domains, and lead verification, validation, and documentation activities.

The role requires strong system architecture and integration skills, with experience in ISO 13485 and cross-functional teamwork.