Suhel S.
Quality & V&V Engineer – FDA 21 CFR Part 820/11, ISO 13485, ISO 14971, IEC 62304 | CSA-aligned NPS Validation | 6+ yrs in MedTech
- Role
- Test Engineer at Tecmag, Inc
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Suhel S.
Software Test & Quality Engineer with over 6 years of experience in the medical device…
Experience
Test Engineer
Aug 2024 — Present · Houston, TX, US
Designing and executing test plans for functional, integration, cybersecurity, and regression testing of the Magnetica 3T compact MSK extremity MRI system (FDA Class II, in development); maintaining complete traceability and defect logs.• Conducting end-to-end validation and risk assessment of non-product software in compliance with FDA 21 CFR Part 820 and ISO 14971 requirements for 510(k) submission.• Collaborating with Quality team to review validation deliverables and ensure alignment with ISO 13485 QMS documentation requirements.• Conducting exploratory testing to uncover edge cases and improve methodology.• Developing statistical analysis plans for MRI system safety and performance testing.
Education
Aliah University
Bachelor of Technology (B.Tech.), Mechanical Engineering
2011 — 2015
Michigan Technological University
Master's degree, Biomedical Engineering
2017
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