Sandeep Kumar Baratam
Senior Design Engineer | Medical Devices | Regulatory Compliance (ISO 13485, FDA, EU MDR) | Risk & Quality Management (ISO 14971, FMEA, CAPA) | Sustenance Engineering | Verification & Validation | Windchill
- Role
- Design Engineer (Labeling & Documentation) at Capgemini Engineering
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sandeep Kumar Baratam
Medical Device Design Engineer with 6.5+ years of experience in design control…
Experience
Design Engineer (Labeling & Documentation)
Sep 2023 — Present · Bengaluru, IN
Managed medical device labeling and documentation, ensuring compliance with ISO, FDA, and EU MDR regulations.Handled Engineering Change Orders (ECOs) and conducted peer reviews in Windchill PLM, ensuring the integrity and accuracy of documentation.Updated IFUs, product labels, and XML-based technical manuals for regulatory compliance, utilizing Arbotext Editor for XML authoring.Coordinated e-labeling content management using Adobe Experience Manager, ensuring accurate asset activation and deactivation.Collaborated with cross-functional teams to validate translated manuals, ensuring quality and consistency across languages.Developed and maintained checklists for compliance verification, ensuring all required documentation was accurate and aligned with regulatory requirements.Supported internal and customer audits, providing compliance documentation and facilitating seamless audit processes.Technical Skills: Adobe Experience Manager, Adobe Illustrator, Adobe InDesign, Windchill, Arbotext Editor
Education
Aditya Institute of Technology and Management
Bachelor of Technology - BTech
2016 — 2019
Sri Venkateswara Polytechnic College - India
Diploma of Education
2013 — 2016
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