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 hiring@novintix.com
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