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.