Labelling Engineer

Project overview

This is a contract Labelling Engineer role in Pune, supporting medical-device product teams working on the named PDLM and MLD projects. The core requirement is medical-device labelling, with work focused on checking artwork, labels, stickers, and IFUs against released requirements and preparing verification and release documentation. The description specifies a B.Tech in Mechanical Engineering, 3–5 years of overall experience, and immediate availability; it also calls for change-request handling, review coordination, and team training.

DOORS, Windchill, and RTC are named in the workflow, although the description does not separately state a required level of prior experience with each tool. No additional preferred skills or specific regulatory standards are stated; work mode is also unspecified.

Responsibilities

• Collect the RfS and list of Artworks details for Labeling verification from the Project lead/TPD team.
• Verify the Artworks/Labels, IFU and stickers according to latest released Labeling requirements.
• Prepare the Labeling Verification Report and share for review with the SCR (Regulatory) team.
• Create and prepare the labeling verification report view in DOORS.
• Create the Quick release and release the labeling verification report along with review evidence sheet in Windchill.
• Create the RfS (change request) for deviations and defects in the RTC tool.
• Review and approve the pre-released Artworks/Labels, Stickers and IFU in point-6 tool.
• Verification of Labeling requirement document according to the change request updates.
• Train the team for labeling verification activity.
• Participate in the Stand-up, impact assessment and project meetings.
• Coordinate with the respective team through email communication and scheduling a meeting.
• PDLM Project (Sunstone and Sunstone smart)

Requirements

• Medical device labelling
• Verification of artwork, labels, stickers, and IFUs against released labelling requirements
• Labelling requirement verification and change/deviation documentation
• B.Tech in Mechanical Engineering

Project details

• Start: flexible
• Remote: onsite
• Location: India, IN