Mechanical Engineer

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 [Confidential Information]