Senior Mechanical Design Engineer

Job Summary:

As a Mechanical Design Engineer, you will contribute to the design, development, and testing of innovative medical devices in compliance with ISO 13485 and regulatory standards. You will support the design team with concept generation, engineering design, prototyping, and ensuring the manufacturability and reliability of devices.

Responsibilities:

• Assist in concept generation, detailed engineering design, and prototyping of medical devices.
• Perform 3D CAD modeling, drafting, and engineering calculations to ensure product performance and reliability.
• Collaborate with cross-functional teams to meet product specifications, performance, and compliance requirements.
• Conduct design feasibility studies and support risk assessments for mechanical components.
• Assist in testing and validation activities, including preparation of test protocols and analysis of results.
• Perform Design for Manufacturing (DFM) and Design for Assembly (DFA) efforts to streamline production.
• Release the designs for production purposes.
• Coordinate with the production team for smooth transfer of designs to the production floor, prepare necessary documents for the production purposes.
• Work with suppliers and vendors to source materials and components.
• Coordinate with vendors for small batch manufacturing, customized components manufacturing.
• Participate in internal design reviews and support documentation for regulatory submissions.
• Stay updated with industry trends, materials, and manufacturing processes relevant to medical devices.

Skills Required:

• Proficiency in CAD software (e.G., SolidWorks, AutoCAD), GD&T, Tolerance Analysis, Engineering design.
• Good understanding of materials science and manufacturing processes.
• Familiarity with ISO 13485, medical device file, design control activities and basic regulatory compliance standards.
• Analytical skills for problem-solving and design optimization.
• Strong communication and teamwork abilities.
• Attention to detail and a commitment to quality assurance.

Educational Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related field with 2+ years of experience in product design and manufacturing.