Design Engineer (Medical Devices)

Infosys; Pune District; On-site; INR 1,100,000 - 2,100,000; Full time

Job summary

Infosys is seeking a Design Engineer with 5–8 years of experience in medical device product development. The role focuses on mechanical design, design controls, DFMEA, risk management, and thorough design documentation to ensure regulatory compliance and quality across the development lifecycle.

You will lead cross-functional design efforts, craft robust technical drawings, and support verification and validation activities, while driving improvements and cost optimization.

Qualifications

• 5–8 years of experience in medical device product development.
• Strong knowledge of Design Controls, DFMEA and risk management.
• Experience with design documentation and change control.
• Familiarity with ISO 13485, ISO 14971, and FDA design control requirements.
• Experience in regulated product development environments.

Responsibilities

• Lead mechanical design and development activities for medical device products.
• Apply Medical Device Design Control processes throughout the product development lifecycle.
• Develop concepts, detailed designs, and engineering solutions for new and existing products.
• Create and maintain design inputs, design outputs, verification, validation, and design reviews.
• Conduct DFMEA and participate in risk assessment activities.
• Perform risk management activities in accordance with regulatory requirements.
• Generate and maintain technical drawings, specifications, BOMs, and engineering documentation.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Support design verification and validation testing activities.
• Drive design improvements, cost optimization, and product reliability initiatives.
• Ensure compliance with industry standards, quality systems, and regulatory requirements.

Skills

Mechanical design

DFMEA

Risk management

Design controls

Design documentation

Cross-functional collaboration

Education

MTech

BE/BTech

Tools

SolidWorks

AutoCAD

PLM tools

Job description

Job Summary

We are seeking a highly motivated Design Engineer with 5 to 8 years of experience in Medical Device Product Development. The ideal candidate will have strong expertise in Mechanical Product Design & Development, Design Controls, DFMEA, Risk Management, and Design Documentation. This role involves driving new product development activities while ensuring compliance with medical device regulations and quality standards.

Roles & Responsibilities

• Lead mechanical design and development activities for medical device products.
• Apply Medical Device Design Control processes throughout the product development lifecycle.
• Develop innovative concepts, detailed designs, and engineering solutions for new and existing products.
• Create and maintain design documentation including design inputs, design outputs, verification, validation, and design reviews.
• Conduct DFMEA (Design Failure Mode and Effects Analysis) and participate in risk assessment activities.
• Perform risk management activities in accordance with applicable regulatory requirements.
• Generate and maintain technical drawings, specifications, BOMs, and engineering documentation.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Support design verification and validation testing activities.
• Drive design improvements, cost optimization, and product reliability initiatives.
• Ensure compliance with industry standards, quality systems, and regulatory requirements.

Technical Requirements

• Strong experience in Mechanical Product Design & Development.
• Hands-on experience with Medical Device Design Controls.
• Expertise in DFMEA and Risk Management methodologies.
• Experience in design documentation and engineering change management.
• Knowledge of product lifecycle management and design transfer processes.
• Strong understanding of manufacturing processes and engineering fundamentals.
• Excellent problem-solving, analytical, and communication skills.

Additional Responsibility

• Prior experience in the Medical Devices Industry.
• Familiarity with ISO 13485, ISO 14971, and FDA design control requirements.
• Exposure to design verification and validation processes.
• Knowledge of CAD tools such as SolidWorks or equivalent.
• Experience working in regulated product development environments.

Educational Requirement

MTech, Bachelor of Engineering, BE

Preferred Skills

• Technology - CAD - AutoCAD
• Technology - Embedded Software - Medical Devices

Service Line

Engineering Services