Mechanical Engineer

About the Role

Luxshare is a globally recognized leader in advanced manufacturing and technology solutions, expanding its presence in the medical device industry. As part of this growth, a new engineering hub has been established in Singapore to strengthen product development and manufacturing worldwide.

We are looking for a Mechanical Engineer to contribute to the design and development of sophisticated medical devices. The selected candidate will be essential throughout the product lifecycle, collaborating closely with diverse teams to deliver reliable, manufacturable, and regulatory-compliant designs.

Key Responsibilities

• Develop mechanical components, assemblies, and subsystems for medical devices, progressing from concept to design verification.
• Create and update 3D CAD models, engineering drawings, BOMs, and related product documentation aligning with company and customer standards.
• Conduct engineering analyses such as tolerance stack-up, material selection, and design considerations for manufacturability and assembly efficiency, ensuring cost-effective and robust solutions.
• Construct, test, and troubleshoot engineering prototypes; perform root cause analysis and apply design enhancements based on testing outcomes.
• Collaborate with multidisciplinary teams including electrical, software, quality assurance, manufacturing, and NPI to satisfy functional, quality, regulatory, and manufacturing criteria.
• Coordinate with suppliers and manufacturing to assess component feasibility, production methods, tooling, and materials.
• Manage engineering change processes by preparing and maintaining design documentation, drawings, and revision records.
• Participate in design reviews, risk assessment sessions, and Failure Mode and Effects Analysis (FMEA) to identify and address technical risks.
• Ensure compliance with medical device industry standards, customer expectations, and internal quality management systems.
• Perform any additional tasks as assigned by management.

Candidate Requirements

• Proficient in 3D CAD design and Geometric Dimensioning and Tolerancing (GD&T), preferably using SolidWorks.
• Hands-on experience with mechanical design, prototype development, and testing procedures.
• Strong analytical abilities and keen attention to detail when solving problems.
• Effective communication and teamwork skills in collaborative, cross-functional environments.
• Experience or knowledge in computational Finite Element Analysis (FEA) simulation and rapid prototyping is advantageous.
• Familiarity with medical device product development lifecycle and regulatory frameworks such as ISO 13485 and FDA 21 CFR Part 820 is a plus.
• Professional working proficiency in Mandarin is considered beneficial.

Educational Background & Experience

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or closely related disciplines.
• Minimum of two years’ experience in mechanical design or product development is typically expected.

Technical Expertise

• Hands-on experience designing electromechanical assemblies with a solid grasp of DFM and DFA principles.
• Knowledge of material selection, surface finishing, and manufacturing processes such as CNC machining, injection molding, and stamping.

Why Join Luxshare

• Contribute to pioneering medical device engineering capabilities based in Singapore.
• Engage with impactful, innovative healthcare technology projects.
• Be part of an expanding global company with strong execution and growth potential.
• Opportunities for professional development, leadership roles, and international experience.

Additional Information

The position may require occasional travel to supplier or manufacturing locations.