Medical Devices Labeling Engineer

Tata Elxsi; Pune District; Hybrid; INR 1,200,000 - 2,000,000; Full time

Job summary

Tata Elxsi, Inc. seeks a Senior Engineer / Specialist to lead medical device labeling programs in Pune. You will ensure compliance across major global regulations, develop IFUs, and manage labeling change processes.

You will engage with design, quality, and regulatory teams to ensure accurate documentation and successful product launches. The role requires hands-on experience with Loftware Cloud/Spectrum, Windchill/Agile PLM, and strong CAD/graphics tools, with attention to detail and

Qualifications

• Proven experience in medical device labeling and regulatory documentation.
• Hands-on or working knowledge of Windchill PLM and Agile PLM systems.
• Familiarity with global labeling requirements across US, Canada, EU MDR, Australia, LATAM and EMEA.

Responsibilities

• Develop and manage product labeling to ensure compliance with FDA, EU MDR, Health Canada, Global countries, UDI, and ISO 20417/ISO 15223.
• Collaborate with cross-functional teams to develop label content and IFU/Operations Manuals.
• Create labeling input and specification documents.
• Lead design reviews for label artwork, specifications, IFUs, and marketing collaterals.
• Develop and update labeling specifications, artwork files, and supporting documentation; coordinate translation requests.
• Review FAI reports, verify final content, and support barcode grading/qualification.
• Provide support to resolve technical and operational labeling issues.
• Conduct design reviews for updated documents and complete DCR reviews in a timely manner.
• Create and route Labeling Change orders in PLM using Windchill/Agile.

Skills

Medical device labeling

Regulatory documentation

Loftware Cloud

Loftware Spectrum

Adobe Creative Suite

Windchill PLM

Agile PLM

Global labeling requirements

Regulatory standards IEC 60601/ISO 204

Cross-functional collaboration

Education

Bachelor/Master in Mechanical/Bio-medical

Tools

Windchill

Agile PLM

Job description

Senior Engineer / Specialist

Key Responsibilities:

• Develop and manage product labeling to ensure compliance with FDA, EU MDR, Health Canada, Global countries, UDI, and standards such as ISO 20417 and ISO 15223.
• Collaborate with cross-functional teams to develop label content and support the creation of Instructions for Use (IFU) and Operations Manuals.
• Create labeling input and specification documents.
• Lead and participate in design review meetings for label artwork, specifications, IFUs, and marketing collaterals.
• Develop and update labeling specifications, artwork files, and supporting documentation; coordinate translation requests.
• Review First Article Inspection (FAI) reports, verify final content, and support barcode grading and qualification.
• Provide support to resolve technical and operational labeling issues.
• Conduct design reviews for updated documents and complete Document Change Request (DCR) reviews in a timely and objective manner.
• Create and route Labeling Change order in PLM and ensure effective change management coordination using PLM tools such as Windchill and Agile.

Required Skills & Experience:

• Proven experience in medical device labeling and regulatory documentation.
• Proficiency in Loftware Cloud and Loftware Spectrum (hands-on or working knowledge).
• Strong command of Adobe Creative Suite (Illustrator, Photoshop, etc.).
• Hands-on or working knowledge of Windchill PLM and Agile PLM systems.
• In-depth understanding of global labeling requirements, including US, Canada, EU MDR, Australia, LATAM, and EMEA regions.
• Familiarity with regulatory standards such as IEC 60601, ISO 20417, and ISO 15223.
• Experience working in multidisciplinary teams.
• Excellent interpersonal, written, and oral communication skills.
• Strong organizational and project coordination abilities.
• High attention to detail and commitment to quality.

Educational Qualification:

• Degree preferred, MTech / BE/ BTECH( Mechanical/Bio-medical/ E