Key Roles & Responsibilities:
· Design and develop mechanical components and assemblies for medical devices as per regulatory and functional requirements.
· Prepare 2D/3D CAD models, detailed engineering drawings, and BOMs.
· Conduct feasibility studies, tolerance analysis, and design verification.
· Support prototype fabrication and testing of medical equipment components.
· Collaborate with R&D and testing teams to validate design performance, reliability, and safety.
· Conduct design modifications based on test results and clinical feedback.
· Ensure mechanical designs comply with ISO 13485, FDA, and other relevant medical device standards.
· Support risk assessment, DFMEA, and design history documentation.
· Work closely with QA/RA teams to prepare design inputs/outputs as per DHF requirements.
· Provide design support to production and process engineering teams during pilot and mass manufacturing.
· Identify cost-effective materials and manufacturing methods without compromising quality and safety.
· Troubleshoot design-related issues during manufacturing or field use.
· Work with electrical, electronic, biomedical, and software teams for integrated product development.
· Coordinate with suppliers and vendors for component development, tooling, and validation.