Kaela Leonard Email & Phone Number

Boston, Massachusetts, Us

• Provide clinical support for customers looking to acquire human biologic samples• Interface with customers to determine sample needs and requirements• Conduct data analysis support and copy writing for EUA and FDA submissions for client’s existing product• Develop customer specific clinical investigation documents such as informed consent, protocol, and case report forms

Allston, Ma, Us

• Successfully led US based clinical trials in pulmonology, navigating numerous involved parties and ensuring study completion• Oversees the setup of study sites in the US including device training, protocol training, and compliance with protocol requirements• Participates in study results analysis• Provides support for French-based team with European-specific activities such as CE mark renewal• Ensure adherence of clinical studies with company SOPs• Interfaces with global marketing and US-based sales team on US based clinical activities• Active participant in cross-departmental discussions involving product improvement and new product development

Medford, Ma, Us

• Led investigation into alternative material option, requiring iterative interaction with potential vendors as well as with manufacturing team with input from marketing• Responsible for protocol development for FDA appropriate trials and clinical sections of FDA submission• Primary interface with IRB, principal investigators, and medical monitors• Managed study sites including setup, data collection and data output• Responsible for vendor and timeline management• Responsible for data integrity and accuracy throughout the clinical trial lifecycle• Actively participated in board meetings

Medford, Ma, Us

• Led usability studies to build data set for self-collection 510k submission to FDA, ultimately leading to successful 510k clearance in November 2019• Led day-to-day operations of clinical testing of device prototypes• Responsible for the training of clinical staff according to GCP standards

Medford, Ma, Us

• Led investigation into alternative material option• Developed system for anticoagulating blood during collection with novel blood collection technique (TAP system)• Determined testing procedures for ensuring that blood quality meets necessary standards• Performed clinical testing of device prototypes on human volunteers and assessing device performance and collected blood quality.• Documented experiments to enable the integration of research findings into device development in preparation for FDA submission• Interfaced with design and development team through design review and device feedback• Wrote procedures for anticoagulant preparation and deposition into device

Medford, Ma, Us

Boston, Ma, Us

Taught: Engineering Calculus I-III, Linear Algebra and Matrix Theory, and Multivariable Calculus

Houghton, Mi, Us

• Entrepreneurial Lead for National Science Foundation I-Corps team; won top award in cohort• Designed business canvas model for start-up company developing a medical device to determine ABO-Rh blood type based on the fundamental work done in my PhD research• Involved cost analysis, market research for competitors, partners and customers • Conducted over 100 customer discovery interviews with potential customers, partner, suppliers and competition in a 7-week period.• Recommended path forward for start-up company based on insights gained during customer discovery interviews• Transformed the design of a microfluidic device enabling the transition from laboratory research to a viable commercial product

Houghton, Mi, Us

Objective: To create a custom-fabricated microdevice that can be used to test for the ABO-Rh blood type of an unknown sample by way of subjecting the sample to an alternating current dielectrophoretic field.Researching AC Dielectrophoresis in medical micro-devices: • Exploring theoretical connection between Dielectrophoresis and Maxwell-Wagner Membrane Relaxations • Completed a study of the rupturing rates of human erythrocytes when subjected to 1kHz alternating current dielectrophoretic field• Studying the movement of erythrocytes in a 1MHz AC field as well as the movement of modified erythrocytes (without the ABO-Rh antigens)• Determining a method for removing the ABO-Rh antigens from the human erythrocytes• Exploring the change in dielectrophoretic cross-over frequency based on blood typeDesign and fabricate microdevices:• Pattern on Si wafers using soft photolithography and a UV mask aligner in a clean room environment. • Design and fabricate plated electrodes using a six inch sputter system and soft photolithography techniquesExperimental design & Analysis of data:• Image analysis via customized Zeiss Automeasurement Software program• Statistical analysis, scaling, image manipulationTrained in safety precautions for a BSL2 lab:• Biosafety Cabinet, Centrifuge, Plasma generator, etc.Mentoring 4 undergraduate researchers on individual erythrocyte electrokinetic projects14 presentations, 3 papers and 8 awards

Mississippi State, Ms, Us

• Graduate level Process Computations, taught by Dr. Adrienne Minerick• Responsible for creating homework solutions and grading homeworks

Mississippi State, Ms, Us

• Tutored 2 student-athletes to SouthEastern Conference All-Scholastic Honors (Spring 2009)• Tutored various student athletes in all subject areas, mentoring them to excel in both academics as well as athletics• Learned various study techniques to assist students• Learned to motivate and teach student athletes

Mississippi State, Ms, Us

I was a PhD candidate at Mississippi State University studying the effect of an alternating current dielectrophoretic field on human erythrocytes in a medical microdevice until I transferred with my advisor to Michigan Technological University.

Notre Dame, In, Us

• Responsible for 40 students as they spent 6 weeks studying in London, UK (resident safety and knowledge of the city)• Teaching Assistant for “Energy and Society” taught by Dr. Frank Incropera

Notre Dame, In, Us

• Tutored student athletes in mathematics (Calculus I thru Differential Equations)• Ran multi-student tutoring sessions in mathematics over school breaks

Notre Dame, In, Us

Objective: To stabilize liposome formation with calcium phosphate and encapsulate polystyrene molecules with these liposomes. (Research Advisor: Dr. Elaine Zhu)• Designed and implemented project based on the synthesis and stabilization of liposomes• Assisted graduate students with their research• Trained graduate and undergraduate students on the confocal microscope

Notre Dame, In, Us

• Homework grading for Differential Equations in the Fall of 2005• Conducted two weekly help sessions in the Spring of 2006 • Teaching assistant for Business Calculus II

Phd, Chemical Engineering

Phd, Chemical Engineering

Bachelor Of Science, Chemical Engineering; Biomolecular Engineering

High School Diploma