Mechanical 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 enhance our global product development and manufacturing capabilities.

We are seeking a Mechanical Engineer to support the design and development of complex medical devices. This role is integral to our product development cycle, working closely with cross-functional teams to deliver robust, manufacturable, and regulatory-compliant designs.

You will play a key role in delivering engineering solutions for global medical device customers, supporting projects from concept development through design verification, design transfer, and manufacturing. By working closely with cross-functional teams, you will ensure mechanical designs are innovative, reliable, manufacturable, and compliant with applicable regulatory and quality standards.

Key Responsibilities

• Design and develop mechanical components, assemblies, and subsystems for medical devices from concept through design verification.
• Create and maintain 3D CAD models, engineering drawings, bills of materials (BOMs), and product documentation in accordance with company and customer requirements.
• Perform engineering analyses, including tolerance stack-up, material selection, and Design for Manufacturability (DFM) and Design for Assembly (DFA), to ensure robust and cost-effective designs.
• Build, evaluate, and troubleshoot engineering prototypes, conducting root cause analysis and implementing design improvements based on test results.
• Collaborate with cross-functional teams, including electrical, software, quality, manufacturing, and NPI engineers, to ensure designs meet functional, quality, regulatory, and manufacturing requirements.
• Work with suppliers and manufacturing teams to evaluate component feasibility, manufacturing processes, tooling, and material selection.
• Support engineering change activities by preparing and maintaining design documentation, drawings, and revision records.
• Participate in design reviews, risk assessments, and Failure Mode and Effects Analysis (FMEA) to identify and mitigate technical risks.
• Ensure designs comply with applicable medical device standards, customer requirements, and internal quality management processes.
• Any other duties as assigned by management

Key Requirements

• Proficiency in 3D CAD design and GD&T; SolidWorks preferred
• Hands-on experience with mechanical design, prototyping, and testing
• Strong analytical and problem-solving skills with attention to detail
• Good communication and teamwork skills in a cross-functional environment
• Computational FEA simulation and rapid prototyping skill is a plus
• Understanding of medical device product development lifecycle and regulatory requirements (ISO 13485, FDA 21 CFR Part 820) is a plus
• Professional working proficiency in Mandarin is a plus

Qualifications & Education

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field
• Typically 2+ years of experience in mechanical design or product development

Technical Experience

• Experience with mechanical design of electromechanical assemblies, with a good understanding of DFM and DFA principles.
• Familiarity with materials selection, surface finishing, and manufacturing processes (CNC machining, injection molding, stamping)

Why Join Luxshare

• Build next-generation medical device engineering capabilities in Singapore
• Work on high-impact, innovative healthcare technologies
• Be part of a fast-growing global organization with strong execution capability
• Access to career growth, leadership opportunities, and international exposure

Additional Requirement

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