Product Design Engineer – Medical Devices

Staff Engineer – Mechanical Engineering

Location: Gurugram (Hybrid)

Experience: 6–11 Years

Job Summary

We are seeking an experienced Staff Engineer – Mechanical Engineering to lead the design and development of complex mechanical and electro-mechanical medical devices. The ideal candidate will drive product development from concept through commercialization, collaborate with cross-functional teams, mentor engineers, and ensure compliance with medical device design and regulatory standards.

Key Responsibilities

• Lead the design, development, and optimization of complex mechanical and electro-mechanical systems.
• Translate customer and clinical requirements into engineering specifications and robust product designs.
• Develop innovative design concepts, conduct feasibility studies, and drive prototype development and testing.
• Create detailed engineering drawings, 3D models, and manufacturing documentation using CAD tools.
• Apply GD&T, DFM/DFA, tolerance stack-up analysis, and engineering best practices throughout the product development lifecycle.
• Perform design verification, validation, root cause analysis, and implement corrective actions for complex engineering issues.
• Evaluate materials, manufacturing processes, and technologies to optimize product performance, quality, and cost.
• Collaborate closely with Manufacturing, Quality, Regulatory Affairs, Clinical, Marketing, and Project Management teams to ensure successful product development.
• Ensure compliance with medical device design controls, engineering standards, and applicable regulatory requirements.
• Support innovation initiatives through technology exploration, invention disclosures, patents, and continuous product improvements.
• Mentor junior engineers and provide technical leadership across cross-functional teams.
• Contribute to process improvements, engineering best practices, and organizational capability development.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 6–11 years of experience in mechanical product design and development.
• Strong experience in designing complex mechanical or electro-mechanical products.
• Proficiency in CAD modeling and engineering drawings.
• Hands-on experience with GD&T, tolerance analysis, and DFM/DFA principles.
• Strong understanding of materials, manufacturing processes, machining, molding, sheet metal, and assembly techniques.
• Experience in product verification, validation, and prototype development.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in cross-functional teams and lead technical initiatives.

Preferred Qualifications

• Experience in the Medical Device, Healthcare, or regulated product development industry.
• Knowledge of Design Controls, Design History File (DHF), ISO 13485, and applicable medical device regulations.
• Experience with CAE/FEA tools for design optimization.
• Exposure to risk management methodologies (FMEA) and design verification/validation.
• Experience mentoring engineers and leading technical workstreams.
• Patent, innovation, or new technology development experience is an added advantage.

Key Skills

• Mechanical Product Design
• Electro-Mechanical Systems
• CAD (Creo/SolidWorks/CATIA/NX)
• GD&T
• DFM/DFA
• Tolerance Stack-up Analysis
• CAE/FEA
• Materials & Manufacturing Processes
• Product Development
• Prototype Development & Testing
• Root Cause Analysis
• Design Verification & Validation
• Cross-functional Collaboration
• Medical Device Design Controls (Preferred)
• Technical Leadership & Mentoring