Lead Design Engineer

Overview

Lead R&D efforts across product development phases for medical device platforms, ensuring design decisions, verification, and documentation meet user, regulatory, and business requirements.

What you'll do

• Lead end-to-end platform-level testing and lab management.
• Collaborate with Design & Development, Systems Engineering, and cross-functional teams.
• Develop, update, and optimize designs using design-space understanding and engineering fundamentals.
• Implement DFSS rigor and use empirical, statistical, and analytical tools to drive design decisions.
• Incorporate manufacturing principles early and manage design integration/transfer risks.
• Own design verification deliverables, including protocols, results summaries, formal design reviews, and verification content in the Design History File.
• Lead implementation of design control best practices and support quality systems, change control, and compliance with safety regulations.

What you'll need

• 7–12 years of engineering/technical experience, including 3 years project and team leadership.
• Degree in a relevant engineering field is required (e.g., Mechanical, Industrial & Production, Chemical, Materials Engineering).
• Six Sigma knowledge with Black/Greenbelt certification, or DFSS knowledge.
• Experience required in test method development, validation strategy, design verification & validation strategy execution, and fixture design & development.
• Proficiency in solid mechanics/mechanics of materials and statistical methods/tools.
• Design controls expertise and experience with traditional and modern fabrication techniques.
• Proven experience leading CAPAs and design-defect analysis/remediation.

Nice to have

• Strong exposure to Six Sigma and Lean methodologies.
• Prior experience in Medical Devices.
• CAD/CAE exposure (SolidWorks, AUTOCAD, PRO-E) specializing in mold flow/structural designs/CFD/plastics domain.
• Knowledge of risk management methodologies (e.g., EURA, FMEA).

Details

• Primary work location: IND Bengaluru - Technology Campus.