Senior Design Engineer

Overview

Senior Design Engineer responsible for design verification, test method development and validation, equipment and fixture management, and regulated medical device product development.

What you'll do

• Lead test method and measurement system development, validation, and optimization.
• Create and execute verification protocols and maintain Design History File verification records.
• Analyze design verification data using statistical measures and engineering methods.
• Develop, validate, troubleshoot, and maintain test equipment, fixtures, and methods.
• Collaborate with engineering and cross-functional teams to make product requirements verifiable and measurable.
• Implement DFSS and DFX practices to improve manufacturability, reliability, usability, and safety.
• Coach junior engineers and technicians on project deliverables.

What you'll need

• Bachelor’s degree in mechanical or biomedical engineering with 5–8 years of experience in medical device or regulated industry.
• Alternatively, a master’s degree in mechanical or biomedical engineering with 4+ years of experience.
• Expertise in test method development, validation strategy, and execution.
• Expertise in fixture design and development.
• Experience with design controls, design verification and validation, and medical regulatory standards.
• Proficiency in solid mechanics and statistical methods or tools.
• Experience leading CAPAs, design-defect analyses, non-conformances, and remediation.

Nice to have

• Experience with SolidWorks or electromechanical systems.
• Experience in high-volume manufacturing processes.
• Experience developing and commercializing medical devices.
• DFSS training or certifications.

Details

• Location: Bengaluru, India.