Caroline Pisani Hord Email & Phone Number

Oakland, Ca, Us

San Francisco Bay Area

• Lead new product design, development and implementation of delivery devices and novel injection tools/aids for biologic therapeutics.• Develops and oversees strategy for mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various medical device designs. Responsible for overseeing complex engineering analyses and reviewing results to inform development strategy.• Responsible for the direct of cross-functional teams and technical management of CMOs in establishing effective partnerships. • Regularly interface with staff and leaders in Commercial Marketing, Clinical Science, Contract Manufacturing, Pharmaceutical Development, Packaging Development, Quality, and Regulatory Affairs.

Boulder, Co

Product Development• Conducted validation testing for products in development, including medical software and in vitro diagnostic devices.• Isolated blood products for use in bench testing with instrument.• Created specifications according to NCCLS/CLSI standards and report layout mock-ups for software related to 510(k) submissions.• Worked with machinists to design custom step drill for machining parts for instrument production.Regulatory & Quality Assurance• Established claims and strategic plans for FDA 510(k) submission of in vitro diagnostic device for monitoring blood coagulation• Managed FDA 510(k) submission, including delegation of tasks, completion and compilation ofsubmission documents, and regulatory compliance with CFR requirements• Drafted and validated protocols to demonstrate safety and effectiveness of pre-market devices. • Created new SOPs for handling instrument service events across departments, internal instrument calibrations, and annual FDA Establishment Registrations• Completed complaint evaluation and handling from all service eventsClinical• Maintained IRB protocols and renewal for continuation of clinical studies.• Responsible for the planning of clinical studies, including patient recruitment and creation of study related documents such as protocols, case report forms, informed consent, and study tools to investigational sites• Managed and maintained clinical files to ensure compliance with the approved protocol and Good Clinical Practice regulatory requirements

Boulder, Co

• Managed biomedical in vitro diagnostic device development project by ensuring compliance with regulatory requirements and planning data collection for FDA 510(k) submission.• Responsible for writing IRB-approved research protocol to ensure humanprotection during clinical studies, including study procedures and methods for data collection, analysis, storage, and confidentiality. In addition, composed IRB-approved subject consent forms in compliance with 45 CFR 46 (Protection of Human Subjects).• On-going support for instrument and reagent testing.• Co-authored research abstract submission for Shock Society 2016 conference in regards toclinical hemostasis monitoring.

• Evaluated assignments, exercises, and quizzes for students taking the Thermodynamics course at the University of Portland.• Responded to questions regarding course material submitted by students to an online course forum.

Portland, Oregon

• Tested force and position sensitivity of actuators using LabVIEW software to meet the design criteria for a bioreactor• Modeled various bioreactor hardware components using SolidWorks and worked with machinists to produce prototype parts for testing• Created project documentation for the assembly process of the bioreactor

Evaluated technical reports and memorandum written by students for the Materials Science Laboratory.

San Francisco, Ca

• Created a software package using the programming language Python to interpret, analyze, and produce quality filtered DNA sequences. • Designed various laboratory tools using SolidWorks and utilized the 3D printer available to the laboratory.

Master Of Science (M.S.), Bioengineering And Biomedical Engineering

Bachelor Of Science (B.S.), Mechanical Engineering

Activities and Societies: Biomedical Engineering Society - Vice President; Alpha Lambda Delta - Honor Society for First Year StudentsCum.