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Celvin Fouse

Oak Ridge, TN • adiizx@r.postjobfree.com • 865-***-****

Relevant Experience

Integra LifeSciences: Cincinnati, OH, Quality Engineer I (Jul. 2019 – Feb. 2020) Post Market Surveillance Remediation Project, (Jul.2019 – Feb. 2020)

· Interfaced with project management to provide daily reports of self-designed work pace of key deliverable completion

· Assessed Service and Repair events to determine possible adverse event reporting

· Participated in all activities pertaining to customer feedback review in order to determine reportable adverse event eligibility

· Handled and reviewed customer complaints throughout the multiple device products manufactured on site

· Reviewed manufacturing prints of the Mayfield cranial stabilization system to discover common complaint areas within the designs

· Performed risk management using FMEAs to identify possible future adverse events

· Met strict deadlines for time sensitive drafting and submittal of Medical Device Reports (MDR) of Form FDA 3500A to FDA

· Parsed FDA’s MDR adverse event reporting codes such as Device Problem Codes for writing MDRs Zimmer Biomet: Parsippany, NJ, Systems Validation Engineer I (Sep. 2018 – Jan. 2019) Delmia Distributed Numerical Control (Delmia DNC) Project, (Sep. 2018 – Jan. 2019)

· Lead and contributed to validation planning, risk assessment, system design specification, qualifications, and remediation efforts

· Provided technical validation guidance to all Zimmer Biomet locations to ensure consistency in approach / purpose

· Executed, confirmed, and documented test results for Installation Qualifications on 50 CNC equipment

· Lead training for operators and operator supervisors on new critical software usage on production floor

· Successfully transferred over 500 CNC operation programs to new database system

· Confirmed CNC operations and documentation accompanies all product part families in database system

· Interfaced with project management to provide daily regular reports

· Met strict project deadlines for time sensitive project Zimmer Biomet: Warsaw, IN, Manufacturing Engineer (Nov. 2017 – Sep. 2018) Feature Control Plans and Assessments (FCA & FCP) Project, (Nov. 2017 – Apr. 2018)

· Created / altered FCPs and FCAs to meet process control performance and quality standards

· Process development and tool design experience

· Analyzed measurements to designate critical and non-critical tolerances for over 50 medical device production prints

· Sampled produced product parts to ensure statistical accuracy for FDA quality standards

· Experience with reviewing Gage R&R and measurement system verification studies

· Experience with Orthopedic Salvage System (OSS) designs

· Completed FCP work on 7 knee stem types and OSS knee limb salvage components

· Created presentation on corrected and reviewed critical features / tolerances for all OSS variations Page 2 of 2

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Equipment Qualifications (EQ) and Installation Qualification (IQ) Project, (Apr. 2018 – Sep. 2018)

· Drafted and executed EQs and IQ for both CNC and manual machines

· Machines such as: CNC/ manual hone, ultrasonic cleaners, centrifugal polishers, hydraulic/pneumatic presses, etc.

· 5-person team worked on Installation Qualification Validations for 300+ machines

· Drafted protocol test methods to qualify and release equipment for production

· Implemented the approval and set up of new in-process manufacturing materials to save time and consumables

· Executed protocol test methods to qualify and release equipment for production

· Implemented dust collection methods for deburring process on pedestal grinders / sanders to improve safety in the workplace

· Investigated and identified missing manufacturing materials as a part of Corrective Action / Preventive Action (CAPA) Mitral Valve Retractor Design & Product Development: UT Knoxville, Team Research Manager (Aug. 2016 – May 2017)

· Research Manager for a 4-person medical device design and development team

· Successfully created working prototype while incorporating design needs for a cardiothoracic surgeon from UT Medical Hospital

· Design process utilized 3D modeling, weekly process assessment documentation, and validation reports

· R&D, cGMP, and SOP writing experience

Forensic Anthropology Center: UT Knoxville, Research Laboratory Assistant (Jan. 2015 - May 2016)

· Laboratory research technician experience within a National Institute of Justice (NIJ) project

· NIJ Project Assistant: Human decomposition research team member

· Prepared, maintained, and assisted various decomposition studies of donated cadavers for research

· OSHA safety training and clean work environment experience Skills

· Software: MATLAB, OpenSim 3.3, Inventor, CAD, SolidWorks, Microsoft Office Suite, Mini Tab, XA, Document Viewer, Siemens NX, Unigraphics 3-D modeling, Delmia DNC, Factory Net, Trackwise, Oracle (R12), Agile (PLM)

· Technical: GD&T, pFMEA Validation testing, Quality/ Inspection requirement, IQ/EQ/OQ/QVP/QP/IQSR, Site-wide software installation, Design History Files (DHF)

· Relevant collegiate coursework: Advanced Biomaterials, Tissue Engineering, and Dynamic Human Modeling & Simulation Education

Bachelor of Science in Biomedical Engineering

University of Tennessee- Knoxville/ Knoxville, TN

· Graduated May 2017

Involvement

Engineering Mentor - Mentee Program: UT Knoxville, Biomedical Mentor (Mar. 2015 – May 2017)

· Mentor freshman and sophomores in the College of Engineering (Leadership position)

· Specialize in working with Biomedical Engineering majors

· Overseer of five freshmen and sophomore mentees (students) University of Tennessee Pride of the Southland Marching Band, Leadership (Fall 2016 – Summer 2017), Member (2013 - 2017)

· Squad Leader for a 350+ member collegiate marching band (Leadership position)

· Directly lead and managed 46 other marchers by teaching performance music and drill

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