Labeling Engineer
Tata Elxsi · Posted Oct 27
Design and technology services, product engineering, systems integration, and digital transformation solutions
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About the role
Tata Elxsi is a design and engineering services company, and this role sits within its medical device labeling and technical publications function. The work covers product labels, packaging artwork, IFUs, operations manuals, and related technical documentation for medical devices. The Labeling Engineer develops and maintains these deliverables while ensuring compliance with global regulatory requirements, design control processes, and quality management system standards, and supports product development, change management, registrations, and Notified Body reviews.
What you will do
- Develop and maintain Product Labels, Packaging Labels, Ancillary Labels, Box Carton Artwork, IFUs, Operations Manuals, and Service Documentation.
- Collaborate with Regulatory Affairs, Quality, Engineering, Packaging, Manufacturing, and Marketing teams to gather and define labeling requirements.
- Create and maintain Product Labeling Strategy (PLS) documentation and labeling plans for new product development and sustaining activities.
- Perform Label Gap Assessments and implement remediation activities arising from regulatory, product, packaging, or market-specific requirements.
- Create and manage labeling artwork using approved graphic and authoring tools.
- Manage country-specific localization and distributor labeling requirements.
- Support Label Verification & Validation (V&V), Formal Label Reviews (FLR)
- Drive labeling-related change management activities, including ECN, ECO, LCE, CAPA, and regulatory-driven changes.
- Conduct impact assessments and support root cause investigations and corrective action implementation for labeling-related issues.
- Manage document review, approval, and release activities through PLM systems.
- Support technical documentation and labeling packages for regulatory submissions and Notified Body reviews.
- Coordinate and perform in-country reviews of translated labels, IFUs, manuals, and artwork with Local Regulatory Affairs representatives to ensure content accuracy and regulatory compliance.
- Support continuous improvement initiatives for labeling processes, systems, and workflows.
Skills used in this role
What the employer is looking for
- Bachelor's Degree in Mechanical Engineering, Packaging Engineering, Biomedical Engineering, Industrial Engineering, or related field .
- 3+ years of experience in Medical Device Labeling, Technical Publications, Packaging Artwork, or Regulatory Documentation.
- Strong understanding of Medical Device Design Control and Product Development Processes .
- Experience developing and maintaining: Product Labels, Packaging Labels, IFUs, Operations Manuals, Technical Documentation
- Knowledge of: FDA Medical Device Labeling Requirements, EU MDR, ISO 13485, ISO 15223-1 Medical Device Symbols, UDI Requirements, IFU and Medical Device Labeling Standards
- Experience supporting Notified Body submissions, reviews, and audit activities .
- Experience with label verification, validation, and change control processes .
- Strong analytical skills with the ability to identify issues, perform root cause analysis, and drive corrective actions.
- Experience working with cross-functional stakeholders across Regulatory, Quality, Engineering, Packaging, and Manufacturing teams.
Preferred qualifications
- Experience with Loftware Labeling Platform.
- Experience with Windchill PLM systems.
- Knowledge of Packaging Development and Artwork Approval Processes.
- Experience with Localization and Translation Management.
- Understanding of Software GUI and SaMD labeling requirements.
- Experience with Regulatory Submissions and Global Product Registrations.
- Knowledge of IEC 60601 and related medical device safety standards.
- Familiarity with Requirement Management tools (e.g., DOORS).
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
PR Newswire
Tata Elxsi delivers healthy revenue growth of 3.4% QoQ and 15% YoY in Q2 FY'272026-10-13
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PR Newswire
Tata Elxsi delivers steady growth at 2.8% QoQ and 14.5% YoY in Q1 FY272026-07-14