Mechanical Engineer – Medical Devices

About the role

Luxshare is establishing a Singapore engineering hub to support the development of advanced medical devices. We are looking for a Mechanical Engineer to design, develop and validate mechanical components and assemblies that meet stringent regulatory and manufacturing requirements.

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 and product documentation.
• Perform engineering analyses such as tolerance stack‑up, material selection, DFM and DFA.
• Build, evaluate and troubleshoot prototypes, conduct root‑cause analysis and implement design improvements.
• Collaborate with electrical, software, quality, manufacturing and NPI teams to ensure functional, regulatory and manufacturability compliance.
• Work with suppliers to assess component feasibility, tooling and manufacturing processes.
• Support engineering change activities and maintain accurate design revision records.
• Participate in design reviews, risk assessments and FMEA to mitigate technical risks.

Required profile

• Proficiency in 3D CAD design and GD&T (SolidWorks preferred).
• Hands‑on experience with mechanical design, prototyping and testing.
• Strong analytical and problem‑solving abilities with attention to detail.
• Effective communication and teamwork in a cross‑functional environment.
• Knowledge of medical device product development lifecycle and regulatory standards (ISO 13485, FDA 21 CFR Part 820) is a plus.
• Professional working proficiency in Mandarin is a plus.

Required skills

• SolidWorks (3D CAD)
• Geometric Dimensioning & Tolerancing (GD&T)
• Tolerance stack‑up analysis
• Design for Manufacturability (DFM) and Design for Assembly (DFA)
• Rapid prototyping
• Finite Element Analysis (FEA) simulation