Design Engineer

We are seeking a talented and motivated Design Engineer to join our dynamic team. The Design Engineer will be responsible for conceptualizing, designing, and developing innovative medical devices and components, ensuring they meet stringent quality standards and regulatory requirements. This role involves close collaboration with R&D, manufacturing, and quality assurance teams to bring new products from concept to market.

Key Responsibilities:

• Develop and refine designs for orthopedic implants and surgical instruments using CAD software.
• Create detailed 3D models, 2D drawings, and Bills of Materials (BOMs).
• Conduct design validation and verification activities, including prototyping and testing.
• Collaborate with cross-functional teams (R&D, Manufacturing, QA) to ensure design feasibility and manufacturability.
• Research and implement new materials, technologies, and design methodologies.
• Ensure designs comply with relevant medical device regulations and standards (e.g., ISO 13485, FDA guidelines).
• Prepare technical documentation for design history files and regulatory submissions.