Design Engineer-Medical Devices

Job description

Mechanical Designer - Plastics Design ·         Candidate Shall have good experience in CAD tools like Solid works & Creo for modeling, assembly and detailing including drawing conversions. ·         Identifying the suitable material, Creating EBOM, DFM/DFA. ·         Good at hand calculation of the design. ·         Shall be able to apply GD&T and perform Tolerance stack-up analysis for components/Sub-system. ·         Shall be able to select materials with minimum guidance. ·         Create DFMEA and identify relevant product risks. ·         Good in Plastics, Sheet metal, casting and fabrications design and development. ·         Knowledge in Test fixtures design & development based on component/sub-system functionality. ·         Shall have hands-on experience in Engineering Change management. ·         Work with supplier, procurement engineer to complete the Prototype. ·         Requirements, Design, implementation, test and integration of his Unit in accordance with the higher-level Requirement and - Design specifications / architectures. ·         Reliability and Serviceability of the system / subsystem / component. ·         Complying to all applicable medical standards / regulations such as CE and FDA. ·         Working closely with all the other team members both R&D team members (Like Systems, Verification, Norm compliance etc..) and cross functional stakeholders (Like Service, Quality, Regulatory, Marketing, Clinical etc…)  for the projects. ·         Provide technical support to suppliers and other departments to fulfill project and production needs. ·         Support localization activities. ·         Knowledge of IEC 60601 standards is preferred. Experience required: Required Skills and Qualifications: - Bachelor’s degree in Mechanical engineering or science discipline, or equivalent experience. - A minimum of 4 to 8 years of experience in establishing and maintaining regulated supplier management systems. - Engineer quality and ensure compliance for raw materials, components, finished products etc. - Excellent communication skills in English (written and verbal). - Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing. - Ability to drive progress, take initiative, and achieve results. - Experience with technical drawings, specifications of parts. - Experience in ISO 9001, 13485 a plus.