PLM Consultant

5 days ago

pune, India Tata Elxsi Full time

Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT. Tata Elxsi’ s Medical Device and Healthcare practice is ISO 13485 certified.


Responsibilities:

  • Lead the evaluation and selection of a SaMD-focused PLM system, considering factors like regulatory compliance, development lifecycle traceability, and integration capabilities.
  • Define and document user requirements specific to SaMD development processes.
  • Develop and implement a comprehensive PLM system implementation plan, considering SaMD development workflows and regulatory milestones.
  • Configure and customize the PLM system to meet our specific needs for managing software source code, requirements, and design documents.
  • Integrate the PLM system with existing engineering tools (e.g., software development tools, version control systems) and quality management systems (QMS) to ensure a closed-loop development process.
  • Develop and implement data migration strategies for existing SaMD product data, ensuring traceability and version control.
  • Train and support users on the new PLM system, focusing on SaMD-specific workflows and functionalities.
  • Ensure the PLM system adheres to relevant SaMD regulations (e.g., IEC 62304, FDA 21 CFR Part 820).
  • Continuously monitor and optimize the PLM system to improve efficiency, traceability, and compliance within the SaMD development lifecycle.
  • Identify opportunities to leverage the PLM system for advanced functionalities like risk management and design control.
  • Stay up-to-date on the latest PLM trends and technologies specific to the SaMD industry.


PLM System Implementation and Support


  • Analyse PLM needs for an organization specifically catering to Software Medical Devices.
  • Analyse and suggest suitable PLM tools as per above needs.
  • Create an end-to-end PLM process and define all the details. (Ideation phase to End of Life Phase of a product)
  • Plan the implementation of Product Lifecycle Management (PLM) system, including installation, configuration, and integration with existing business systems.
  • Customize PLM solutions to meet the specific needs of the organization, including developing and deploying new features and functionalities.


Job Location- Pune

Experience - 10 to 15 Years

*No SAP PLM*

*Direct Consultant Role – 6 months to 1 year*

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