Design Engineer (Medical Devices)

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.

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