SHAUNASEE M. KOCEN

adpkr0@r.postjobfree.com

512-***-****

EXECUTIVE SUMMARY

• Research engineer with 10+ years of experience in Medical Device Products Design from proof of concept to product launch.

• Familiar with new Product Development Cycle, Device Design Control, Validation/Verification, Risk Management and Scale Up per ISO 13485 and 14971.

• Multidisciplinary experience working directly with doctors and scientists to translate User Needs to Engineering Design Inputs.

PROFESSIONAL EXPERIENCE

EKF Life Sciences, Elkhart IN Oct 2019 – Current

R&D Scientist

• R&D Scientist for Medical Device Manufacturer, Fermentation and Protein Purification company.

• Responsible for R&D projects from start to finish.

• Synchronized global R&D departments; wrote the Design Controls and Product Development SOPs.

• Developed documentation for production in GMP, 21 CFR Part 820, and ISO 13485 and 14971.

Steel Warehouse, South Bend IN Sept 2018 – Oct 2019

Mechanical/Industrial Engineer Consultant

• Engineered Steel Manufacturing Line design, installation, maintenance, and troubleshooting

• Designed manufacturing and automation equipment in SolidWorks and AutoCAD.

• Implemented LEAN & 5S manufacturing methods to increase slitter productivity 11%.

• Used research and Six Sigma tools to analyze defects on Slitter line.

Ohmx Corporation, Evanston IL Sept 2017 – Apr 2018

Senior Research Engineer

• R&D Engineer for Biotech Start-Up commercializing an in vitro diagnostics device with a novel electrochemical assay with prototype automated liquid handling system.

• Performed root cause analysis on a prototype diagnostic device to identify and quantify failure modes.

• Implemented design history files (DHF) to track failures and assigned risk priority based on frequency and severity of failure events.

• Executed and tracked Process Manufacturing Changes on prototype instrument when necessary.

• Used critical thinking and problem solving skills to create innovative testing methods to quantitatively determine prototype failure modes, used food coloring and colorimetric assay to determine dispensed volume as low as 0.5 µL, for example.

F Cubed, LLC, South Bend IN Nov 2010 – May 2017

Senior R&D Engineer

• Part of Biotech Start-Up Team that commercialized an automated Point-of-Care in vitro diagnostics device.

• Translated complex scientific techniques to patented automated medical device.

• Worked with doctors to determine user needs, translated to design inputs, and established validation/verification criteria.

• Worked with medical, regulatory, and engineering determine patient/user impact of medical devices.

• Changed design parameters as necessary to improve function, for example: added engineering controls when users were unable to withdraw sample volumes within the specified tolerance.

• Designed, performed, and analyzed experiments/tests to optimize assay and compare to predicate devices.

• Brainstormed potential user failure modes and mitigated with engineering controls or user literature.

• Created documentation for ISO 13485, 14971 and 9001 and GMP.

EDUCATION

The University of Notre Dame Notre Dame IN

Master of Science in Bioengineering 2018

Thesis: miRNA Biomarkers from a Human Cardiac Stress Model

The University of Texas Austin TX

Bachelor of Science in Human Biology 2006

PATENTS

Ivie, Leslie et al. 2017. Sample Preparation Device and Method of Use.

• US Patent 9,670,479 issued on 06/06/2017.

TECHNICAL SKILLS

Computer Skills: AutoCAD; SolidWorks; Microsoft Office; Linux.

Life Sciences: ISO 5, 6, 7 Clean Room; biochip manufacture; rapid point of care diagnostics and immunoassays; in vitro processing; cell culture and sorting; hospital, physician, and home healthcare devices; lateral flow assays; pharmaceuticals.

Regulations and Safety: OSHA 30-hour General Industry Training; familiar with ISO, DIN, GMP, CDC biosafety regulations, and EPA environmental quality regulations. IRB and 510(k) experience.

Biology: microRNA analysis; PCR; RT-qPCR; gel electrophoresis; DNA and RNA isolation and purification; ELISA; fluorescent microscopy; UV-Vis; iPSC cell culture and differentiation to cardiomyocytes; bacteria culture techniques (aerobic and anaerobic); sterile techniques.

LEADERSHIP AND SERVICE

2015 Aerospace and Mechanical Engineering Graduate Student Organization Vice President

2014 International Genetically Engineered Machine (iGEM) Team Ivy Tech: Silver Medal

• Volunteer Scientific Advisor

2013 OSHA 30-hour General Industry Training

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