Design Engineer

Job Description Design Engineer (Medical Devices)

Experience: 5 to 8 Years
Location: Pune
Qualification: Bachelor's or Master's Degree in Mechanical Engineering (Mandatory)
Domain Preference: Medical Devices
Employment Type: Full-Time

Job Summary

We are looking for an experienced Design Engineer with a strong background in Medical Device Product Design and Development. The ideal candidate will be responsible for designing innovative medical products, driving product development activities, supporting manufacturing, and ensuring compliance with medical device quality and regulatory standards.

Key Responsibilities

• Design and develop mechanical components and assemblies for medical devices.
• Create 3D models, engineering drawings, and product documentation using CAD tools.
• Participate in the complete product development lifecycle from concept to commercialization.
• Perform design calculations, feasibility studies, and tolerance analysis.
• Work closely with R&D, Quality, Manufacturing, and Regulatory teams.
• Support prototype development, verification, validation, and testing activities.
• Conduct design reviews and implement engineering change requests.
• Ensure products comply with industry standards and regulatory requirements.
• Collaborate with suppliers and manufacturing teams for product realization.
• Drive continuous product improvements and cost optimization initiatives.

Required Skills

• 5 to 8 years of experience in Mechanical Design Engineering.
• Strong experience in Medical Device Product Development.
• Proficiency in CAD tools such as SolidWorks, Creo, or similar software.
• Strong understanding of GD&T, Tolerance Stack-up Analysis, and Engineering Calculations.
• Knowledge of manufacturing processes including machining, injection molding, sheet metal, and assembly.
• Experience in Design Verification and Validation activities.
• Strong problem-solving and analytical skills.
• Excellent communication and stakeholder management skills.

Preferred Skills

• Experience with PLM/PDM systems.
• Knowledge of ISO 13485 and Medical Device Regulations.
• Experience in risk management and design control processes.
• Understanding of DFM (Design for Manufacturing) and DFA (Design for Assembly).
• Exposure to new product development (NPD) projects.

Educational Qualification

• Bachelor's or Master's Degree in Mechanical Engineering.
• Medical Device industry experience is highly preferred.