System Engineer

About the Job

Luxshare is a global leader in advanced manufacturing and technology solutions, with a growing footprint in the medical device sector. As part of our strategic expansion, we are establishing a Singapore-based engineering hub to provide world-class medical device design and development services to clients across the global market.

We are seeking a System Engineer to support client medical device development programs. Working with multidisciplinary engineering teams, this role translates user/customer needs into engineering requirements and supports system integration, verification, validation, and design transfer activities.

As a design service provider, Luxshare does not own client device designs or regulatory submissions. This role is responsible for delivering high-quality systems engineering deliverables while maintaining technical traceability throughout each engagement.

Key Responsibilities

Support systems engineering activities across the full product lifecycle in accordance with ISO 13485.

Develop and maintain user needs, design inputs, system requirements, interface specifications and requirements traceability.

Support system architecture, requirements decomposition and interface definition.

Support system integration, verification, validation and design transfer.

Participate in design reviews and technical discussions.

Support risk management activities in accordance with ISO 14971.

Prepare systems engineering documentation and technical reports.

Collaborate with mechanical, electrical, software, quality, regulatory and manufacturing teams.

Support engineering change assessments and requirements updates.

Investigate technical issues and support root cause analysis.

Ensure engineering deliverables comply with applicable regulations and standards.

Any other duties assigned by management.

Key Requirements

Good understanding of systems engineering and medical device design control.

Knowledge of requirements management, risk management, system verification and validation principles.

Strong analytical thinking and structured problem-solving skills.

Good communication and teamwork skills.

Ability to work independently with minimum guidance.

Professional working proficiency in Mandarin is a plus.

Qualifications & Education

Bachelor's degree in Systems Engineering, Electrical & Electronic Engineering, Mechanical Engineering, Biomedical Engineering, Mechatronics Engineering, Software Engineering, or a related field.

3 to 5 years of experience in systems engineering, product development, or related engineering roles.

Project & Delivery Experience

Experience supporting multidisciplinary product development projects is preferred.

Exposure to requirements development, verification, validation, and/or system integration is an advantage.

Experience preparing engineering documentation and technical reports is preferred.

Experience across the full medical device development lifecycle is a plus.

Technical Experience

Good understanding of systems engineering, requirements management and design verification.

Knowledge of ISO 13485, ISO 14971 and applicable medical device standards.

Familiarity with PLM, requirements management, risk management, and issue tracking tools (e.g., Windchill, DOORS, Agile, Jama, JIRA, or equivalent) is an advantage.

Why Join Luxshare

Work on innovative healthcare technologies.

Gain hands-on experience across the medical device development lifecycle.

Receive mentoring from experienced engineering professionals.

Access career growth and international exposure.

Additional Requirement

This role may require occasional travel to customers, suppliers, or manufacturing sites.