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.

- Robust organizational and project coordination abilities.

- High attention to detail and commitment to quality.

Educational Qualification

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

📌 Medical Devices Labeling Engineer (Pune)
🏢 Tata Elxsi
📍 Pune