Job Title: Senior Mechanical Design Engineer

Experience: 4-5 years Location: Bengaluru, India # of openings: 1

Responsibilities:

• Collaborate with the interdisciplinary team to design and develop the mechanical components of a drug delivery device.
• Create and optimize 3D CAD models, drawings, and specifications for the device, ensuring functionality, size, durability, and user-friendliness.
• Conduct simulations and analysis to evaluate and optimize the design for performance, size, manufacturability, and cost-effectiveness.
• Select and evaluate materials, components, and manufacturing processes that meet the requirements of the target market and regulatory standards.
• Find, select, and qualify such vendors that can undertake the manufacturing activities.
• Coordinate with selected manufacturing vendors to develop prototypes, tooling, dies and address issues to ensure high-quality production.
• Develop and execute testing plans to validate the design, performance, and safety of the device.
• Assist in the preparation of documentation for regulatory submissions and other applications.
• Collaborate with the quality assurance and regulatory teams to ensure compliance with relevant standards and guidelines.
• Continuously monitor industry trends, new technologies, and best practices to drive innovation and improvements in the design and development process.

Requirements:

• Bachelor's or Master’s degree in Mechanical Engineering or a related field.
• 3+ years of experience in mechanical design and development in the medical device industry.
• Proficiency in 3D CAD software (e.g., SolidWorks, Inventor, or similar).
• Strong knowledge of materials, manufacturing processes, and engineering principles related to medical devices.
• Experience with design for manufacturability, assembly, and cost optimization.
• Experience with translating a device to batch/mass manufacturing is a plus.
• Familiarity with medical device regulations, standards, and quality management systems (e.g., ISO 13485, FDA 21 CFR Part 820, IEC 60601).
• Excellent problem-solving, communication, and teamwork skills.
• Ability to work independently and manage multiple projects in a fast-paced, deadline- driven environment.
• Passion for improving healthcare access and outcomes for underserved populations.