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ELAINE CHRISTINE MACASLAN

812-***-**** ac6hrm@r.postjobfree.com

OBJECTIVE

Apply my biomedical engineering skills and regulatory compliance knowledge to a design and/or development position at a medical device company. EXPERIENCE

Ken Block Consulting, Richardson, TX

July 2017-July 2018: Biomedical Engineer

● Worked directly with medical device manufacturers to ensure successful 510(k) submissions, create FDA presubmissions, respond to 483s and warning letters and conduct remediation, and perform a recall in the United States and Canada

● Developed quality system improvement plans, UDI implementation plans, FMEAs, gage repeatability and reproducibility analyses, and a training presentation on consent decrees

● Contributed to 21 CFR 820 and ISO 13485 gap analyses and ISO 14971 risk management

● Reviewed corrective and preventive actions (CAPAs) and verification & validation testing for regulatory compliance

● Gained experience with Class I, II, and III devices, including endoscopes, spinal monitoring, patient specific implants, cranial implants, dental handpieces, and other electromechanical products

● Worked with internationally distributed cross-functional teams of colleagues and clients on a daily basis

● Edited technical and regulatory documentation and FDA and client correspondence in Japanese and English

● Represented Ken Block Consulting at FDA Regulatory Education for Industry conference (Washington DC 2017), Medtec Japan (Tokyo 2018), and MedCon

(Cincinnati 2018)

UT Southwestern Medical Center Laboratories, Dallas, TX and Los Angeles, CA June 2012-May 2017: Researcher

Design & Development

● Designed, built, calibrated, and maintained a state-of-the-art electrophysiology rig

● Designed and tested a medical imaging system that maps blood flow non-invasively, for monitoring heart recovery, decubitus ulcers, and burn surgery

● Studied transcutaneous implant design and microdialysis systems

● Gained direct exposure to biomedical engineering design challenges by observing cases in the pediatric cardiology ICU

Validation Testing & Analysis

● Assessed data integrity from a laser-assisted wound measurement apparatus

● Conducted experiments to study the effects of various growth factors on opacity of keratocytes in the cornea

● Studied biopolymer heart injections to alter the biomechanics of failing hearts

● Performed and analyzed data from tensile testing of polymer fibers intended for stent development

2

Laboratory Techniques & Skills

● Performed two-electrode ion-selective electrophysiology on frog oocytes and extracted mouse muscle cells

● Advanced my skills in mouse & rat handling, surgery (microsuturing), dissection, care, echocardiograms, and breeding

● Studied cellular ion channel expression and pathologies through microbiology techniques

● Assisted with surgical implantation of prototype neural-machine interfaces

● Developed skills in high pressure liquid chromatography, plate reading, and performing ELISA assays, heart staining and imaging, and in vivo and in vitro confocal microscopy

● Gained familiarity with the classic porcine wound healing model

● Observed various animal surgeries and studied heart valves through dissection of a pig heart

Communication & Technical Writing

● Acquired, analyzed, and presented data using Origin, pCLAMP, Clampex, and Clampfit

● Applied my writing skills to grant proposals, the preparation and editing of scientific papers, and the creation of new research plans and ideas

● Wrote and executed FDA validation protocols

Roche Diagnostics Operations, Indianapolis, IN

June-August 2011: Mechanical Engineering Meter Research & Development

● Designed blood glucose meter strip lighting system and steel LCD cradle

● Recommended and presented future design features based on expanded analysis of competitor products

● Independently conducted, revised, and analyzed thermographic imaging testing of blood glucose meters using an environmental chamber Cummins Inc., Columbus, IN

June-August 2010: Filtration Business Unit

● Worked across business units to design, implement, and manage testing the adverse effects of dust ingestion on diesel engines

● Adapted engine performance cells to introduce fine particles for accelerated wear testing in geographically dispersed engineering facilities June-August 2009: Industrial Application Engineering

● Analyzed duty cycle data of diesel engines

● Translated Tier 4 OEM Application Training manuals into Japanese

● Six Sigma Introductory Training, Engine Familiarization Training EDUCATION

UT Southwestern Medical Center (Dallas, TX) – May 2017: Masters in Biomedical Engineering

Coursework included: Bioinstrumentation, Human Physiology, Neural Engineering, Modeling & Simulation, Tissue Engineering, Biostatistics Rose-Hulman Institute of Technology (Terre Haute, IN) – graduated Cum Laude 2012: Bachelor of Science in Biomedical Engineering & Mechanical Engineering 3

Japanese Minor, 6 years of study (2 independent), Level 3 International Proficiency Cumulative GPA: 3.44 / 4.0, Dean’s List 2010-2011, 2008-2009 Coursework included: Tissue-Biomaterial Interactions, Biomechanics, Biomaterials, Genetics, Fluid & Thermal Systems, Thermodynamics, Heat Transfer, Technical & Professional Communications, Electrical Systems, Mechanical Systems PUBLICATIONS & PRESENTATIONS

*Kathryn E. Davis, PhD, *Fadi C. Constantine, MD, Elaine C. MacAslan, BS, Jessica D. Bills, BS, Debby L. Noble, BS, Lawrence A. Lavery, DPM, MPH. Validation of a Laser Assisted Wound Measurement Device for Measuring Wound Volume. Journal of Diabetes, Science, and Technology, 2013.

Design of a New Transducer for Measuring Shear Stresses at the Foot-Shoe Interface E. C. MacAslan, B. Roux, K. N. Lewis, and G. A. Livesay Biomedical Engineering Society National Conference 2012 SELECTED PROJECTS

Senior Biomedical Engineering Design – Rose-Hulman

● Designed a shear stress sensor for the interface between the sole of the foot and the shoe

● Project selected for presentation at the 2012 national Biomedical Engineering Society conference in Atlanta, GA

Introduction to Tissue Engineering – University of Texas at Arlington

● Independently designed a project to investigate methods of binding urinary bladder matrix pieces

Biomedical Engineering Design – Rose-Hulman

● Designed a two-part system to allow a client who is paralyzed from the waist down to play the pedals of a piano

Mechanical Measurements – Rose-Hulman

● Devised an experiment using an Instron to characterize the variation in standard boards used for Taekwondo breaking competitions

● Adapted testing equipment to mimic the shape and striking velocity of a human hand for repeatable, consistent results

● Used MATLAB and Maple to perform uncertainty analysis SKILLS OVERVIEW

● Biomedical and mechanical engineering design and analysis

● Regulatory compliance (21 CFR 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, MDSAP)

● Statistical analyses

● Electrophysiology, microscopy

● RT-PCR, ELISA, immunohistochemistry, cell culture, aseptic technique

● Japanese Language Proficiency Test (Level 3), cultural awareness

● Software: MATLAB, Maple, Origin, EndNote, Clampex, Clampfit, pCLAMP

● Communication: public speaking, writing, social media 4

● Care, handling, surgery, and dissection of research animals

● Leadership, creativity, management (projects, people, deadlines, and time) ACTIVITIES

● Regulatory Affairs Professionals Society

● American Society for Quality

● Association for the Advancement of Medical Instrumentation

● Society of Women Engineers

● Biomedical Engineering Society

● Piano - World Piano Competition Semifinalist (July 2007)

● Sketching, hiking, kayaking, biking

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