Capgemini

Senior ME Design Engineer | 6 to 9 Years | Pune

Job Description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Job Description

A Senior mechanical design engineer responsible to Lead and be an integral part of the team tasked with the development process in medical devices

Primary Skills

  • Experience in Product design and development in Medical Devices
  • Experience in coordinating and leading Design Reviews and the compilation of associated documentation.
  • Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities. 
  • Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements and European regulations like EU MDR, IVDR
  • Experience in working with of Medical Device standards like ISO 14971, IEC 60601, ISO 10993,
  • Proven experience of minimally invasive Medical Device design, development, and manufacturing.
  • Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes. Knowledge and experience with Medical Device sterilisation processes.
  • Proven experience of work with infusion pump and disposable design and testing a distinct advantage.
  • Working knowledge of biocompatible metal and/or polymer materials.
  • Experience in Sheet Metal, Plastic, Casting Component Design
  • Knowledge of manufacturing processes/ tooling construction, their resulting manufacturing defects.
  • Thorough Understanding of GD&T, Tolerance Analysis
  • Expertise In 3D Modelling, Assembly & 2D Drawings (Solid works, Creo)
  • Experience in Vendor management activities
  • Demonstrate a working knowledge of the required activities and deliverables from each of the development phases. 

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fuelled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion. 


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