Rumashree Das

Biomedical Engineer specializing in regulatory affairs and government scheme documentation, with over 3 years of experience in the medical device industry.

Biomedical Engineer (R & D) - Life Bound Technologies Pvt Ltd

(2023-03)

• Led and submitted government as well as grant proposals for MeitY TIDE 2.0, SAMRIDH, BIRAC BIG, BFI BIOME and DST NIDHI Prayas.
• Created and managed grant documentation, including technical writeups, and milestone reports.
• Prepared the company's official pitch deck for grant applications and investor presentations, tailoring content to highlight product strengths, regulatory readiness, and health impact.
• Developed ISO 13485-compliant QMS and technical documentation, improving audit readiness by 25%.
• Drafted over 40+ documents: regulatory dossiers, SOPs, product labeling, and submission files.
• Coordinated with R&D, Quality, and Management to meet regulatory and funding requirements.
• Filed two provisional patent for medical device innovation.

Quality Engineer Trainee - Trivitron Healthcare

(2023-01 - 2023-03)

• Assisted in QA of CT systems, compliance with NABH/AERB standards.
• Performed equipment checks and documented QC data.
• Maintained imaging protocols and calibration schedules for 1 CT unit.

Biomedical Engineer Intern - Jorhat Medical College & Hospital

(2018-08 - 2019-01)

• Observed and toured medical devices and diagnostic units.
• Gained hands-on understanding of CT scan, MRI, and X-ray machine operations.
• Learned the principles and workflows of key diagnostic imaging technologies.

B.Tech - Biomedical Engineering - North Eastern Hill University (2017-08 - 2021-08)

Executive Masters - Medical Technology & Medical Imaging - Skill-Lync (2022-05 - 2023-05)