Mechanical & Physical Engineer | 4 - 6 years | Pune

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.