Mansi K.
Product Development Engineer @Biotex, Inc
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WORK HISTORY
Product Development Engineer @Biotex, Inc
Houston, TX, US
Translated qualitative user insights and clinical workflows into clear, testable design requirements that guided engineering and UX decisions across the product lifecycle.Spearheaded development of Design History Files in alignment with 21 CFR 820 and authored comprehensive risk analyses per ISO 14971 to support regulatory strategy and FDA submissions Led summative usability testing for a next-generation robotic surgical system, evaluating safety, efficiency, and use-related risk across representative surgical workflows in a simulated OR environment.Collaborated with R&D, clinical, regulatory, and marketing teams to create compliant, user-centered IFU and labeling that clearly communicate indications, contraindications, warnings, and use of the deviceLed cross‑functional DFMEA, PFMEA, and UFMEA activities, translating failure modes into actionable design and process controls that strengthened the risk management file and supported ISO 14971 compliance.Authored bench performance test protocols defining test objectives, sample sizes, acceptance criteria, and data analysis methods to demonstrate safety and performance for regulatory submissions.
EDUCATION
B. M. S. College of Engineering
Bachelor of Engineering - BE, Biomedical/Medical Engineering
Texas A&M University
Master of Engineering - MEng, Biomedical/Medical Engineering
ABOUT MANSI K.
Engineer and researcher focused on turning real clinical needs into safe, intuitive medical devices. Experience spans GI, femtech, catheters and robotic surgery, with strengths in human factors, risk management, RCA and verification/validation.Partner closely with clinicians and product teams to translate user needs into requirements, design and run bench and preclinical studies, and author core design-control deliverables (DHF, FMEAs, IFU, labeling). Worked with contract manufacturers to establish process validations (IQ,OQ,PQ), supplier qualifications. Also building perspective from the venture side through work in due diligence, deal sourcing, and market mapping, and excited by roles that sit at the intersection of clinical insight, product development, and innovation.
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