Available to hire
I am a senior engineer with over 5 years in the medical device field, specializing in regulatory affairs related to labeling and packaging. I have hands-on experience with ISO 13485 and EU MDR standards, and I collaborate with cross-functional teams to ensure compliance and quality. I excel at creating label artwork, collaborating with suppliers, and maintaining traceability across User Needs, Design Inputs, and Design Outputs. In my spare time I enjoy learning new CAD/Design tools and expanding my skill set.
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Intermediate
Intermediate
Language
English
Fluent
Work Experience
Senior Engineer - Labeling & Packaging at Medtronic
September 30, 2021 - April 8, 2025Led label creation for cardiovascular stents and catheters using Adobe Illustrator and Prism 360. Created redlines/blue lines for IFU and MDD labels, prepared labeling reports, and uploaded artifacts to Agile PLM. Performed V&V and DMR activities for label art and drawings, and generated DFM-ready samples. Collaborated with cross-functional teams to ensure ISO 13485 and EU MDR compliance.
Development Engineer at Integra LifeSciences / Hill Rom
May 1, 2019 - November 20, 2020Performed DHF remediation for endoscope products, ensuring ISO 13485 and EU MDR compliance. Reviewed and updated design controls, verification/validation documentation, and essential requirements checklists. Ensured traceability between User Needs, Design Inputs, Design Outputs, and Risk Management Files.
Education
Qualifications
Bachelor of Engineering in Mechanical Engineering
January 1, 2011 - January 1, 2015Master in CAD/CAM
January 11, 2030 - December 25, 2025Industry Experience
Healthcare, Manufacturing, Professional Services
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Intermediate
Intermediate
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