Design Engineer (Medical Devices)

About the Role

Lead mechanical design and development activities for medical device products.

Key Responsibilities

• 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.

Requirements & Tech Stack

• Mechanical Product Design & Development
• Medical Device Design Controls
• DFMEA
• Risk Management methodologies
• Design documentation
• Engineering change management
• Product lifecycle management
• Design transfer processes
• Manufacturing processes
• Engineering fundamentals
• ISO 13485
• ISO 14971
• FDA design control requirements
• Design verification and validation processes
• CAD tools such as SolidWorks or equivalent
• Regulated product development environments

Qualifications

• Strong problem-solving, analytical, and communication skills.
• Prior experience in the Medical Devices Industry.