Job Title
: Mechanical Engineer – Medical Device R&D; / Sustaining Engineering

Location
: Hyderabad

Experience
: 5-12 Years

Job Summary

The Mechanical Engineer will be responsible for mechanical design, development, analysis, verification, validation and sustaining engineering activities for medical-device products. The role will work closely with Systems, Electrical, Software, Quality, Regulatory, Manufacturing and Supplier Engineering teams across the product lifecycle

Key Responsibilities
- Develop and maintain mechanical designs for medical-device products and subsystems.
- Translate system/product requirements into mechanical design requirements and specifications.
- Develop and review 3D CAD models, assemblies and engineering drawings.
- Perform GD&T;, tolerance stack-up and tolerance analysis.
- Conduct mechanical design analysis including strength, structural and material analysis.
- Support material selection and evaluation of plastics, metals and other medical-device materials.
- Design components and assemblies considering DFM/DFA, manufacturability,



reliability and cost.
- Support prototyping, design iterations and engineering builds.
- Develop and execute mechanical Design Verification and Validation (V&V;) activities.
- Prepare engineering test protocols, test reports and technical documentation.
- Participate in Design Reviews and technical design assessments.
- Support DFMEA, risk analysis and risk mitigation.
- Investigate product failures, NCRs, CAPAs and field issues using structured root-cause analysis.
- Support engineering changes, product improvements and sustaining engineering.
- Support supplier/component development and technical issue resolution.
- Support design transfer and manufacturing readiness.
- Maintain engineering documentation and Design History File (DHF) deliverables.
- Support regulatory submissions and responses with appropriate technical evidence.
- Ensure engineering activities comply with applicable medical-device regula

📌 Mechanical Engineer (Hyderabad)
🏢 NovintiX
📍 Hyderabad