Mechanical Engineer

NovintiX; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

NovintiX is seeking a Mechanical Engineer for Medical Device R&D and Sustaining Engineering. The role covers design, development, analysis, verification and sustaining activities across product lifecycles.

You will collaborate with Systems, Electrical, Software, Quality, Regulatory, Manufacturing and Supplier teams to translate requirements into CAD models and drawings, perform GD&T and design verification.

Qualifications

• Mechanical or biomedical engineering degree required.
• Experience in medical-device development and sustaining engineering a plus.
• Proficiency with SolidWorks or Creo and GD&T fundamentals.

Responsibilities

• Develop and maintain mechanical designs for medical-device products and subsystems.
• Translate system and product requirements into mechanical design specifications.
• Create and review 3D CAD models, assemblies and drawings.
• Perform GD&T, tolerance stack-up and tolerance analysis.
• Conduct mechanical design analysis including strength and materials.
• Support DFMEA, risk analysis and documentation.

Skills

GD&T & tolerance analysis

Mechanical design

Engineering drawings

Prototyping & development

Design Controls

DFM/DFA

Quality/regulatory documentation

Statistical analysis (Minitab)

ISO/FDA/IEC knowledge

Material selection

Education

Mechanical Engineering / Biomedical Engineering degree

Tools

SolidWorks/Creo

Job description

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

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.
• Design Controls.
• DHF / technical documentation.
• Knowledge of ISO 14971, ISO 13485, FDA Design Controls and IEC 60601 preferred.
• Minitab/statistical analysis exposure preferred.