Capgemini

System Engineer | 6 to 9 Years | Pune

Posted On

Aug. 26, 2024

Location

Pune, Maharashtra

Experience Level

Experienced Professionals

Job Type

Permanent

Apply By

Oct. 2, 2024

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

Role: System Engineer

Academic Background: bachelor’s degree in engineering life science or other relevant areas

Responsibilities:

Gap assesment with respect to medical device directives/regulations and applicable standards.
Documents system architecture and design control elements by writing documents, reports, and memos.
Collaborates in the translation of customer needs into technical requirements, engaging the field, marketing, service and other functions as needed.
Provides expertise and conducts evaluation of validation and verification activities.
Assist with industry-based standards testing for safety and EMC according to 60601-1
Supports the risk analysis for the project.
Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.
Working in a global delivery model

Primary Skills

5- 8 years of total experience out of which 2-4 years of experience in within medical device industry is mandatory
Good understanding of the QSR / QMS requirements as per 21 CFR Part 820 & ISO 13485:2016
Thorough understanding of requirements management; from user needs through verification and validation; experience with requirements management tools.
Knowledge of requirements traceability and generating trace matrix
Experience in the development of system architectures.
Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, FTA, and FMEA.
Knowledge on MDD 93/42/EEC and MDR 2017/745
Familiarity with the Design Controls in Medical Devices
Working Knowledge on the applicable standards
Experience with EU MDD/MDR Remediation and DHF remediation projects

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.

Jobs at Pune

Oracle

Java Principal Engineer (IC4, 12-15…

Professional

Pune, Maharashtra

System Engineer | 6 to 9 Years | Pune Apply Now

Job Description

Job Description

Primary Skills

Jobs at Pune

More Jobs at Capgemini

Actively Recruiting Companies at Pune, Maharashtra

System Engineer | 6 to 9 Years | Pune