12 Aug
|
Phillips-Medisize
|
Bengaluru
12 Aug
Phillips-Medisize
Bengaluru
Job Overview
Phillips-Medisize is seeking a Product Design Engineer to design and develop creative drug delivery devices in accordance with the Phillips-Medisize Design Development Process (DDP), Design Controls, ISO 13485, and ISO 14971 requirements. The role involves end-to-end product development activities including concept development, detailed design, risk management, engineering verification, and manufacturing support for mechanical and electro-mechanical medical devices.
Key Responsibilities
Design and develop drug delivery devices using NX, SolidWorks, or Creo.
Generate complex 3D models, assemblies, and engineering drawings compliant with ASME Y14.5 and ISO 1101 standards.
Perform engineering analysis including tolerance stack-up analysis, theoretical calculations, and simulations.
Conduct design risk assessments using dFMEA, pFMEA, and ISO 14971 methodologies.
Develop and implement risk mitigation strategies and verification test plans.
Design assembly fixtures, test fixtures, and manufacturing support equipment.
Integrate electronic components and subsystems into product designs.
Select and develop mechanical components including plastic, metal, elastomeric, spring, and sheet metal components.
Support material selection for drug-contacting and non-drug-contacting components.
Create and maintain Design History File (DHF) documentation, Engineering Change Orders (ECOs), and Design Approval documentation.
Perform component verification testing and support engineering investigations.
Collaborate with manufacturing, quality, regulatory, suppliers, and global engineering teams to ensure successful product development and transfer.
Required Qualifications
Bachelor’s degree in Mechanical Engineering, Mechanical Design, or Mechatronics.
3-5 years of product design and development experience.
Minimum 3 years of experience designing medical devices, healthcare products, or drug delivery devices such as auto-injectors, pen injectors, wearable pumps, or relate
📌 Product Design Engineer (Bengaluru)
🏢 Phillips-Medisize
📍 Bengaluru