Job Title: (Senior) Mechanical Design Engineer - Consumables 

Experience: 4-5 years Location: Bengaluru, India # of openings: 1 CTC: Up to 10 LPA 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 design and 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, deadlinedriven environment.