SHRIJANA BARAL SHRESTHA

Conducted Usability studies/formative/summative study for Immunoassay analyzer Wrote protocols, study design/plans, and reports

Project and Lab Lead 2020-2021 • Prioritized and executed increased demand for hand sanitizer during COVID-19 pandemic, connecting with suppliers to find correct container closure system and following SOP's to complete the design control document. • Worked with regulatory, quality, and manufacturing team, ensuring product compliance and qualifications. • Ran Design Validation testing trials, writing design control, design verification, and design validation documentation. • Conducted supplier selection for packaging and filing, writing documentation. Usability and Human Factors subject matter expert 2019-2020 • Conducted formative and summative usability studies with HFE team and cross-functional product development teams, meeting usability standards of medical device. • Wrote HFE-Reports, following FDA guidelines and IEC 62366-1 Standard for novel and legacy medical devices. Advanced Research Chemist 2016-2021 • Participated in VOC with doctors and nurses on how to improve existing products, collecting feedback, and implementing in new and existing products. • Observed 3M and partner production sites, monitoring processes and quality controls. • Co-developed skin barrier films (Cavilon™ Advanced Skin Protectant, Tegaderm™ CHG dressings): o Evaluated raw materials, prepared, and optimized formulations and recipes, including chemical compositions and glass transition temperatures. o Developed test methods, procedures, and stability studies, analyzing, documenting, and reporting results. • Saved company funds by finding cheaper alternative source of guar, being recognized with 3M’s “Circle of Technical Excellence and Innovation” team award.

• Managed a group of up to 15 Pace Analytical Services employees working at 3M. Served as a point of contact between Pace and 3M, handled client complaints, and worked with HR. • Trained new employees, performing regular review and group meetings, and managing timesheets. • Continued with all the analyst job functions and assignments along with supervisor role.

• Prepared, assisted, and monitored human clinical studies. Prepared and assisted in animal clinical trials. • Formulated products, designed and developed wet chemistry test methods, conducted tests, and analyzed experimental data, reporting results. • Trained new personnel with product formulation, test methods, product evaluation, running validation and verification tests.