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.