Design Engineer (Medical Devices)

Infosys; Maharashtra; On-site; INR 600,000 - 1,200,000; Full time

Benefits offered by this job

Health coverage

Job summary

Infosys is seeking a MECHANICAL DESIGN professional for medical devices in Maharashtra with hands-on experience in design controls, DFMEA, and risk management. You will lead development activities, create design documentation, manage changes, and collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain to ensure compliant, reliable products.

The role emphasizes design transfer, PLM, CAD tools (SolidWorks or equivalent), and experience in regulated product development

Qualifications

• Strong experience in mechanical product design and development.
• Hands-on exposure to medical device design controls and DFMEA.

Responsibilities

• Lead mechanical design and development activities for medical device products.
• Apply Medical Device Design Control processes throughout the product development lifecycle.
• Create and maintain design documentation including inputs/outputs, verification/validation, and design reviews.
• Perform DFMEA and participate in risk assessment activities.
• Generate and maintain drawings, specifications, BOMs and engineering docs.
• Collaborate with R&D, Quality, Regulatory, Manufacturing and Supply Chain across product life cycle.
• Support design verification and validation testing and drive design improvements.

Skills

Mechanical design

Design Controls

DFMEA

Risk management

Engineering change management

Product lifecycle management

Design transfer

Problem solving

Communication

Tools

SolidWorks

Job description

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.

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.

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.