Design Engineer (Medical Devices)

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.

• 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.

• 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.

• 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.

MTech, Bachelor of Engineering, BE

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

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