Mechanical & Physical Engineer | 4 to 6 years | Pune

Job Description

Seeking a detail-oriented and analytical Design & Validation Engineer with expertise in CAD tools (SolidWorks), statistical analysis (Minitab), and risk management methodologies. The ideal candidate will be responsible for supporting the design, development, and validation of engineering solutions with a strong focus on usability, reliability, and compliance with safety and quality standards.

Key Responsibilities:

• Develop and modify 3D models and 2D drawings using SolidWorks and other CAD tools.
• Conduct design validation, reliability testing, and usability assessments for new and existing products.
• Perform statistical analysis using Minitab to support data-driven decision-making in design and testing.
• Lead and document Risk Hazard Analysis, Use FMEA, and Design FMEA activities.
• Create and maintain Design & Development Plans in alignment with project and regulatory requirements.
• Collaborate with cross-functional teams including R&D, quality, and manufacturing to ensure robust product development.
• Support impact analysis, document routing, and risk mitigation planning throughout the product lifecycle.

Required Skills & Qualifications:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
• 4–8 years of experience in engineering design, risk analysis, and product validation.
• Proficiency in SolidWorks and computer-aided engineering (CAE) tools.
• Strong knowledge of Minitab or equivalent statistical software.
• Experience with FMEA, risk management, and design control documentation.
• Solid understanding of materials, manufacturing processes, and engineering principles.
• Excellent communication and documentation skills.

Preferred Qualifications:

• Experience in medical devices, automotive, or aerospace industries.
• Familiarity with ISO 14971, IEC 60601, or other relevant regulatory standards.
• Knowledge of DOE (Design of Experiments) and Six Sigma methodologies.