Safiya Arif Email & Phone Number

Austin, Texas Area

• Ensure high performance and efficiency of the clinical team through the proactive practice of customizing study tools and use of all the company’s resources to resolve issues.• Lead problem solving and resolution efforts to include management of risk, contingencies and issues. • Identify quality issues within the study, implementing appropriate corrective action plans. Escalate findings and action plans to appropriate parties. • Collect information on team performance against contract, customer expectations, and project baselines. • Researched and evaluated state of the art outpatient care biomedical equipment to be utilized by all specialties.• Created a biomedical department budget with 10-year strategic planning which reflected a 10% expense reduction. • Conducted market survey for new generation biomedical technology and studied functional and technical white papers.

Greater New York City Area

Bone Biomechanics Disuse Osteoporosis: • Conducted experiments to test the mechanical endurance of normal, disuse osteoporotic, and Bisphosphonate treated bone tissues, with a working hypothesis that material properties of the bone are relevant to bone fracture (project sponsored by NASA). A study that will ultimately help 14% US population that suffers from either osteoporosis or disuse osteoporosis. • Fashioned a clamp holder to hold 3-5mm bone samples which resulted in 20% efficiency increase across project execution.• Performed microindentation using Bone Indentation Device (BID) to execute the study and validate BID which will be utilized as a more reliable diagnostic equipment to predict the risk of osteoporosis related bone fractures. • Performed statistical analysis of the obtained factual data, ultimately testing the validity of the current hypothesis.Medical Device Design for BPH Electroablation Device:• Successfully designed and developed minimally invasive and disposable catheter for the electroablation of Benign Prostatic Hyperplasia (BPH) which will help treat 8% men under the age of 40 and 50% men under age 60.• Performed functional analysis and design decomposition to compile design input. • Created and maintained Design History Files (DHF) and Division of Materials Research (DMR).• Used CAD/CAE for developing 3D model/ blue print with geometric design and tolerancing (GD&T).• Performed design verification using numerical simulation, phantom model and ex-vivo testing.• Used internal design review processes to validate and compiled documentation. • Gained experience with selecting material such as appropriate catheters, wires and balloons, as well as ASTM &ISO approved polymer and adhesive. • Attained exposure to electrosurgery calculation for developing the ablation device. • Acquired knowledge of DFM and FMEA, as well as reverse engineering processes.

Austin, Texas Area

• Reduced aging queries from 9 months to less than a month, by developing clinical tools such as the Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan. • Developed and delivered training for standardized verification processes. • Managed the project budget for all functional departments as well as execution of necessary scope changes and/or contract modifications. • Facilitated open communication across departments to ensure questions/concerns were addressed quickly and did not impede the progress of the study.

Greater New York City Area

•Conducted experiments to directly prove an increase in certain chemokine/cytokine expression in human PMN’s when co-cultured with melanoma induced endothilial cells •Performed co-culturing, immunohistochemical staining, and immun-fluorescence imaging •Collected, analyzed, and presented experimental data

Greater New York City Area

▪ Prepared proposal for a suturing device to seal Patent Foramen Ovale (PFO), which was sponsored by Columbia Presbyterian Hospital▪ Conceptualized, developed, and produced a PFO suturing device, through collaboration with various surgeons ▪ Attended numerous surgeries in order to perform research and data analysis▪ Validated and performed mechanical testing and improved methodologies for data acquisition ▪ Project selected for patent

Greater New York City Area

•Conducted experiments involving transendothelial transport using bovine retinal endothelial cells •Performed cell culturing, plating, and fixation of bovine retinal endothelial cells •Collected and analyzed experimental data

Master'S Degree, Biomedical/Medical Engineering

Activities and Societies: Biomedical Engineering Bone Journal Club

Bachelor'S Degree, Biomedical/Medical Engineering

Activities and Societies: Biomedical Engineering Society (BMES), Biomedica Engineering Bone Journal Club, Sloan-Kettering Cancer Center.