Responsibilities:

• Undertake complete design and development of medical device consumables, namely infusion sets, reservoirs etc.
• Work in close collaboration with other members of the engineering team to ensure smooth integration of consumables with a drug delivery device.
• Perform design validation, part inspection, and performance testing to verify the reliability of consumables.
• 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.
• Generate Plastic component/System designs that are optimized for production, reliability, regulatory compliance, and cost.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).
• Maintain up-to-date knowledge of regulatory standards and ensure designs comply with all applicable healthcare regulations.
• Prepare technical specifications, reports, and other documentation as required.

Requirements:

• Bachelor's or Master’s degree in Mechanical Engineering with a specialization or significant coursework in Polymer Science & Engineering.
• 3+ years of experience in mechanical designand development of plastic or polymer-based consumables is a must.
• Proficiency in 3D CAD software (e.g., SolidWorks, AutoCAD, 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, ISO 80369, IEC 60601).
• Excellent problem-solving, communication, and teamwork skills.
• Ability to work independently and manage multiple projects in a fast-paced, deadline driven environment.