System Engineer | 6 to 9 Years | Pune
Capgemini
5 - 8 years
Pune
Posted: 17/09/2024
Job Description
Job Description
Role: System EngineerAcademic Background: bachelor’s degree in engineering life science or other relevant areasResponsibilities: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 60601-1Supports 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 Skill
s5- 8 years of total experience out of which 2-4 years of experience in within medical device industry is mandatoryGood understanding of the QSR / QMS requirements as per 21 CFR Part 820 & ISO 13485:2016Thorough 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 2017/745Familiarity with the Design Controls in Medical Devices Working Knowledge on the applicable standards Experience with EU MDD/MDR Remediation and DHF remediation projectsCapgemini 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.
About Company
Capgemini is a global leader in consulting, technology services, and digital transformation. Headquartered in Paris, France, Capgemini provides a wide range of services, including IT consulting, managed services, business process outsourcing, and digital transformation solutions. With over 360,000 employees across more than 50 countries, the company focuses on helping organizations innovate and transform their businesses to remain competitive in a rapidly changing digital landscape. Capgemini is known for its expertise in cloud computing, AI, cybersecurity, and other emerging technologies, working closely with clients to develop sustainable and cutting-edge solutions.
Services you might be interested in
One-Shot Campaign
Reach out to ideal employees in one shot!
The intelligent campaign for reaching out to the ideal audience to whom you can ask for help (guidance or referral).