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 regulations and standards.
- Collaborate with global engineering and cross-functional teams.

Required Technical Skills

- Mechanical Engineering / Biomedical Engineering degree.
- SolidWorks / Creo or equivalent CAD tools.
- GD&T; and tolerance analysis.
- Mechanical design and engineering drawings.
- Plastics, metals, injection moulding, machining and precision manufacturing.
- DFM/DFA.
- Prototyping and product development.
- Mechanical testing and V&V.;
- FMEA / Risk Management.
- Root Cause Analysis.
- Design Controls.
- DHF / technical documentation.
- Medical-device development experience preferred.
- Knowledge of ISO 14971, ISO 13485, FDA Design Controls and IEC 60601 preferred.
- Minitab/statistical analysis exposure preferred.

Apply now by sending your application to [email protected]

📌 Mechanical Engineer (Hyderabad)
🏢 NovintiX
📍 Hyderabad